Comparison of intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery: A randomized, controlled, non-inferiority study | Revista Española de Anestesiología y Reanimación (English Edition)

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Abdelbaser, N.A. Mageed, E.-S.M. El-Emam, M.M ALseoudy" "autores" => array:4 [ 0 => array:4 [ "nombre" => "I." "apellidos" => "Abdelbaser" "email" => array:1 [ 0 => "ibraheem2005@mans.edu.eg" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "N.A." "apellidos" => "Mageed" ] 2 => array:2 [ "nombre" => "E.-S.M." "apellidos" => "El-Emam" ] 3 => array:2 [ "nombre" => "M.M" "apellidos" => "ALseoudy" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Comparación de ibuprofeno y ketorolaco intravenosos para analgesia postoperatoria en niños tratados mediante cirugía de la zona inferior del abdomen: estudio aleatorio, controlado y de no inferioridad" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1475 "Ancho" => 2508 "Tamanyo" => 170665 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0020" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Distribution of the first rescue dose of morphine. PACU: Post anesthesia care unit." ] ] ] "textoCompleto" => "IntroductionLower abdominal surgeries are common procedures in the pediatric population, and are associated with mild to moderate postoperative pain.<a class="elsevierStyleCrossRef" href="#bib0005">1</a> In day surgery, guidelines recommend using adequate opioid-free postoperative analgesia. Opioids are potent analgesics, but their use can be associated with nausea, vomiting, pruritus, respiratory depression, urine retention and delayed discharge from the hospital.<a class="elsevierStyleCrossRef" href="#bib0010">2</a>Non-steroidal anti-inflammatory drugs (NSAIDs) are often used in multimodal analgesia and can alleviate mild to moderate postoperative pain in pediatric patients.<a class="elsevierStyleCrossRef" href="#bib0015">3</a> The use of NSAIDs for postoperative analgesia avoids or reduces the need for opioids.<a class="elsevierStyleCrossRefs" href="#bib0020">4,5</a> Parenterally administered NSAIDs for postoperative analgesia include ketorolac,<a class="elsevierStyleCrossRef" href="#bib0030">6</a> diclofenac,<a class="elsevierStyleCrossRef" href="#bib0035">7</a> piroxicam<a class="elsevierStyleCrossRef" href="#bib0040">8</a> and ibuprofen.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>Intravenous ketorolac has been used for postoperative analgesia, and its analgesic efficacy is comparable to that of morphine. However, given the serious adverse effects associated with ketorolac, including increased intraoperative and postoperative bleeding, gastritis, gastric ulcer, and renal dysfunction, this drug needs to be replaced by other types of non-opioid analgesics.<a class="elsevierStyleCrossRefs" href="#bib0050">10,11</a>Intravenous ibuprofen was only approved in 2009 to control fever and pain,<a class="elsevierStyleCrossRef" href="#bib0060">12</a> and is a safe, effective postoperative analgesic in adults.<a class="elsevierStyleCrossRefs" href="#bib0065">13–15</a> Ibuprofen is associated with fewer gastric, cardiac, renal, hepatic and bleeding side effects than ketorolac due to its more favorable cyclo-oxygenase-1 (COX-1): cyclooxygenase-2 (COX-2) inhibition ratio.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>Only 2 recent studies used intravenous ibuprofen for postoperative analgesia in pediatric patients - one study after tonsillectomy<a class="elsevierStyleCrossRef" href="#bib0080">16</a> and the other after laparoscopic hernia repair.<a class="elsevierStyleCrossRef" href="#bib0085">17</a> To the best of our knowledge, this is the first randomized clinical trial to use intravenous ibuprofen for postoperative analgesia in children undergoing open lower abdominal surgery.This aim of this randomized, controlled, non-inferiority study is to compare the postoperative analgesic effects of intravenous ibuprofen versus ketorolac in children undergoing open unilateral lower abdominal surgery. We hypothesized that the quality of postoperative analgesia achieved with intravenous ibuprofen would be non-inferior to that of intravenous ketorolac. The primary outcome was postoperative opioid consumption during the immediate postoperative period (24hours), and the secondary outcomes were postoperative pain scores, incidence of postoperative fever, and adverse effects associated with intravenous ibuprofen and ketorolac.Materials and methodsEthics and study designThis is a prospective, single-center, randomized, double-blind, non-inferiority, controlled study with two parallel arms. Approval was obtained from the institutional review board of our faculty of medicine (IRB code: R 20.12. 1129) on December 24, 2020, before the start of patient recruitment. The study protocol was registered at pan African clinical trial registry (PACTR202101661828558) prior to patient enrollment. The study has been conducted following the ethical principles of the Declaration of Helsinki, and complies with good clinical practice guidelines. Written consent was obtained from the parents or legal guardians of all study patients.We conducted this study at the University Children's Hospital between December 2020 and June 2021. A total of 66 children aged from 2 to 8 years with American Society of Anesthesiologists (ASA) Physical Status class I-II scheduled for unilateral lower abdominal surgery were recruited. Patients were excluded if they had a history of hypersensitivity to NSAIDs, had received NSAIDS in the 12hours prior to surgery, presented renal or hepatic dysfunction, inflammatory bowel disease, or a history of gastrointestinal bleeding.Randomization and blindingThe study participants were randomized to either intravenous ibuprofen or intravenous ketorolac using computer-generated random number tables to obtain 1:1 patient allocation. Sealed opaque envelopes containing the group assignment were delivered to the operating room on the morning of surgery, and were opened after induction of anesthesia. The anesthesiologist who prepared the study drugs was not involved in the study. The observer who collected the data, the postoperative nursing teams, and the patient’s parents or legal guardians were all blinded to the study group.Anesthetic managementA standardized general anesthesia protocol was used in all patients, and included 0.5mg/kg oral midazolam for premedication 30min before separation from their parents or legal guardians. The patients were monitored in the operating room using pulse oximetry, electrocardiography, non-invasive blood pressure monitor and capnography. General anesthesia was induced with either inhalational sevoflurane or intravenous propofol 2mg/kg, depending on the patient’s age and the accessibility of a peripheral venous line. Thereafter, the patient received 0.5mg/kg atracurium and 2μg/kg fentanyl, followed by insertion of a non-cuffed endotracheal tube of appropriate size. Anesthesia was maintained with 2% sevoflurane delivered in an oxygen/air mixture (FiO2=0.5) under controlled ventilation.InterventionsEach dose of the study drug, ibuprofen or ketorolac, was diluted in 50ml 0.9% saline and was infused over 15min through a large bore (20-22 gauge) venous cannula placed in the largest available peripheral vein. Patients in the ibuprofen group received 10mg/kg intravenous ibuprofen every 6hours for 24hours. Patients in the ketorolac group were given 0.5mg/kg intravenous ketorolac every 6hours for 24hours. Infusion of the first dose of ibuprofen or ketorolac was started 15min before the end of surgery.Postoperative carePatients were transferred to the post anesthesia care unit (PACU) after surgery, where they stayed for 30min. Each patient was given a single intravenous dose of paracetamol 10mg/kg on arrival at the PACU, which was followed by 10mg/kg/6h oral paracetamol syrup. We used the modified Children’s Hospital of Eastern Ontario Pain Scale (mCHEOPS)<a class="elsevierStyleCrossRef" href="#bib0090">18</a> to assess the severity of postoperative pain. The 10 points mCHEOPS consist of 5 parameters including crying, fascial expression, verbal expression, torso and legs. Intravenous morphine 5μg/kg was given for rescue analgesic if mCHEOPS was greater than 3.Data collectionThe primary outcome measure was total morphine consumption in the immediate postoperative period. The secondary outcome measures were postoperative pain score (mCHEOPS), time to first rescue analgesia, number of morphine doses, parent satisfaction (on a 10-point scale: 0 not satisfied and 10 highly satisfied), incidence of early postoperative fever, and incidence of ibuprofen and ketorolac-related adverse effects, including injection site pain, vomiting, epigastric pain, bleeding and allergic reactions. The pain score was assessed at the following time points: in the PACU 15min after surgery, every hour during the first 4 postoperative hours, every 2hours over the following 4hours, and every 4hours thereafter. Early postoperative fever was defined as body temperature above 38°C during the first 2 postoperative days, and was controlled with cold compresses. Patients were actively followed over the phone by caregivers for 48hours after hospital discharge.Sample size and statistical analysisThe sample size was calculated using PASS version 15.0.5 software for Windows (PASS, LLC, Kaysville, UT, USA), using a non-inferiority test for the difference between two means. The study was designed as a non-inferiority trial. The null hypothesis was that postoperative analgesia with intravenous ibuprofen would be inferior to that of intravenous ketorolac. To test the alternative hypothesis of non-inferiority of intravenous ibuprofen compared to ketorolac, the sample size was calculated on the basis of the mean total morphine consumption in the immediate postoperative period. Considering the results of our preliminary study that included 5 patients in each group, the mean (standard deviation) morphine consumption was 18 (8.3) μg/kg/24h in the intravenous ibuprofen group and 17 (7.5) μg/kg/24h in the ketorolac group. The sample size per group of 26 patients achieved 80% power to detect non-inferiority using a one-sided, two-sample t-test. The margin of non-inferiority was 4.5μg/kg/24h. The true difference between the means was assumed to be 1μg/kg/24h. The significance level (alpha) of the test was 0.050. The data were drawn from populations with standard deviations of 8.3 and 7.5. Seven patients were added to each group to compensate for drop outs. Thus, the final sample was 33 patients for each group. The 95% confidence interval (3.9) was less than the margin of non-inferiority (4.5), therefore non-inferiority was confirmed.The Shapiro–Wilk test was used to check the normality of data distribution. Non-parametric variables are presented as median (IQR) and were tested with Mann–Whitney U test. Normally distributed quantitative data were analyzed with the unpaired t-test and are expressed as mean (SD). Categorial variables were analyzed with the Chi-Square test, and are expressed as number and percentage (%). All variables were compared between the 2 study groups. The data were analyzed using IBM SPSS 21.0 (IBM Corp., Armonk, NY, USA) for Windows. Statistical significance was p<0.05.ResultsSixty-six patients were recruited for the study, of whom 7 were excluded: 4 did not meet the inclusion criteria, and 3 refused to participate. Fifty-nine patients completed the study, 30 patients in the ibuprofen group and 29 patients in the ketorolac group (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).<elsevierMultimedia ident="fig0005"></elsevierMultimedia>Patients and Surgical CharacteristicsThere were no significant differences between the ibuprofen and ketorolac groups in terms of patient characteristics and type of surgery (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). Most patients were boys (boys, n=52 vs girls, n=7). The median age (IQR) was 3.2 (3–5.2) years in the ibuprofen group and 4.5 (2.5–6.2) years in the ketorolac group. The surgical procedures were herniotomy (n=39), orchiopexy (n=12) and hydrocelectomy (n=8).<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>Postoperative Analgesic Characteristics and Parent Satisfaction ScoreMean (SD) immediate postoperative morphine consumption (μ/kg) did not differ significantly (p=0.305) between the ibuprofen (16.00 [5.31]) and ketorolac (14.65 [4.61]) groups (<a class="elsevierStyleCrossRef" href="#tbl0010">Table2</a>). Time to first rescue analgesic (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>) did not differ significantly between groups. Mean (SD) time to first rescue analgesic was 3.70 (1.44) h in the ibuprofen group and 3.93 (1.48) h in the ketorolac group, distributed as follows: in the PACU and at 1hour (n=0 in both groups), at the second time point (ibuprofen n=6, ketorolac n=7), at the third time point (ibuprofen n=7, ketorolac n=3) at the fourth time point (ibuprofen n=6, ketorolac n=9), at the fifth time point (ibuprofen n=3, ketorolac n=4) and at the sixth time point (ibuprofen n=8, ketorolac n=6) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). The mean (SD) number of morphine doses during the first 24 postoperative hours was similar (p=0.305) in the ibuprofen (3.20 [1.06]) and ketorolac (2.93 [0.92]) groups (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>). The median (IQR) parent satisfaction score did not differ significantly (p=0.516) between the ibuprofen (8.5<a class="elsevierStyleCrossRefs" href="#bib0035">7–9</a>) and ketorolac (8 [8-9]) groups (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>).<elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia>The reported postoperative pain scores (mCHEOPS) were similar in both the ibuprofen and ketorolac groups at all time points (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>). The median pain score was between 1 and 4 with interquartile range ([0-3] to<a class="elsevierStyleCrossRefs" href="#bib0010">2–5</a>).<elsevierMultimedia ident="fig0015"></elsevierMultimedia>Drug related side effects and postoperative feverThe incidence of postoperative fever was significantly lower (p=0.039) in the ibuprofen (3%) compared to the ketorolac (20%) group (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). The incidence of adverse effects, injection site pain (10% vs 0%), epigastric pain (10% vs 20%), and vomiting (6.6% vs 17%) in ibuprofen versus ketorolac was similar (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). Other NSAID side effects (bleeding and allergic reactions) were not reported in either group.<elsevierMultimedia ident="tbl0015"></elsevierMultimedia>DiscussionIn this prospective, randomized, non-inferiority, controlled clinical trial we compared the postoperative analgesic effects of intravenous ibuprofen and ketorolac in children scheduled for open lower abdominal surgery. Intravenous ibuprofen was non-inferior to ketorolac for postoperative analgesia in terms of postoperative opioid consumption and pain score over 24hours. Furthermore, intravenous ibuprofen was associated with a lower incidence of postoperative fever compared with ketorolac.Non-steroidal anti‑inflammatory drugs have been used as primary analgesics or as a component of multimodal analgesia protocols to control postoperative pain.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> The inclusion of NSAIDs in multimodal analgesia protocols after pediatric surgery reduces postoperative opioid consumption and opioid-related adverse effects, such as vomiting, urine retention, and respiratory depression.<a class="elsevierStyleCrossRef" href="#bib0095">19</a> NSAIDs, including ibuprofen and ketorolac, reversibly inhibit COX-1 and COX-2 enzymes, thereby inhibiting prostaglandin H₂ synthesis, which is a mediator of pain, fever and inflammation.<a class="elsevierStyleCrossRef" href="#bib0100">20</a> COX-1 is present in the gastrointestinal mucosa, kidneys and platelets, while COX-2 is expressed in muscle tissue, including skeletal, cardiac and smooth muscles.<a class="elsevierStyleCrossRef" href="#bib0105">21</a> The analgesic, anti-febrile and anti-inflammatory effects of NSAIDs are mediated through COX-2 inhibition. The adverse effects of NSAIDs, such as bleeding and gastritis, are attributed to COX-1 inhibition.<a class="elsevierStyleCrossRef" href="#bib0110">22</a> The ratio of COX-1 to COX-2 inhibition is 2.5:1 for ibuprofen and 330:1 for ketorolac, which explains the higher incidence of bleeding and gastrointestinal adverse effects of ketorolac in comparison with other non-selective COX-2 inhibitors such as ibuprofen.<a class="elsevierStyleCrossRef" href="#bib0115">23</a>In our study, we chose to compare intravenous ketorolac with intravenous ibuprofen because ketorolac has proven postoperative analgesic efficacy in both adults and pediatric patients. Ketorolac has been used in children to control postoperative pain after various surgical procedures, such as abdominal surgery, cardiac surgery, orthopedic surgery, tonsillectomy, trauma surgery, urological surgery and ophthalmic surgery.<a class="elsevierStyleCrossRefs" href="#bib0120">24,25</a> Saryazdi et al. compared the postoperative analgesic effects of intravenous ketorolac and pethidine in pediatric patients undergoing inguinal herniotomy, and found that ketorolac was superior to pethidine.<a class="elsevierStyleCrossRef" href="#bib0130">26</a> In children, several studies have reported the opioid sparing effect of postoperative intravenous ketorolac.<a class="elsevierStyleCrossRefs" href="#bib0135">27–29</a> Many adult studies have also shown that the postoperative analgesic efficacy of ketorolac is similar to that of tramadol and other opioids.<a class="elsevierStyleCrossRefs" href="#bib0150">30–33</a>In this study, intravenous ibuprofen was non-inferior to intravenous ketorolac in reducing morphine consumption and pain scores in the immediate postoperative period. In line with our results, Dwarica et al. reported that both intravenous ketorolac and ibuprofen obtained similar reductions in postoperative hydromorphone consumption and pain scores in adults who underwent gynecological surgeries.<a class="elsevierStyleCrossRef" href="#bib0170">34</a> The results of a study by Uribe et al. showed that intravenous ibuprofen was superior to ketorolac in reducing postoperative opioid consumption and pain scores in adult patients who underwent arthroscopic knee surgeries.<a class="elsevierStyleCrossRef" href="#bib0175">35</a>Oral ibuprofen is one of the most popular NSAIDs, and has been prescribed for fever and pain for more than 40 years. Intravenous ibuprofen was approved in 2009 for mild to moderate pain and as an adjunct to opioids in multimodal analgesia to relieve moderate to severe pain.<a class="elsevierStyleCrossRef" href="#bib0045">9</a>To the best of our knowledge, this is the first study to use intravenous ibuprofen for postoperative analgesia in children undergoing open abdominal surgery, and the first to compare the postoperative analgesic efficacy of intravenous ibuprofen and ketorolac in pediatric patients. In children, only 3 randomized studies have been conducted to evaluate the postoperative analgesic efficacy of intravenous ibuprofen.<a class="elsevierStyleCrossRefs" href="#bib0080">16,17,36</a> A recent study by Lee et al. showed that combination intravenous ibuprofen and paracetamol was superior to paracetamol alone in reducing postoperative opioid consumption in children who underwent laparoscopic inguinal hernia repair.<a class="elsevierStyleCrossRef" href="#bib0085">17</a> Moss et al. found that a single intravenous dose of ibuprofen significantly reduced postoperative fentanyl consumption in children after tonsillectomy.<a class="elsevierStyleCrossRef" href="#bib0080">16</a> Troendle et al. found that the use of intravenous ibuprofen in children undergoing endoscopic retrograde cholangiopancreatography was associated with a significantly lower incidence of post-cholangiopancreatography pancreatitis and lower postoperative pain scores in comparison with placebo.<a class="elsevierStyleCrossRef" href="#bib0180">36</a>In adult patients, several studies have showed the analgesic efficacy of postoperative intravenous ibuprofen. Intravenous ibuprofen in adult patients reduces postoperative opioid consumption and pain scores following total hip replacement,<a class="elsevierStyleCrossRef" href="#bib0185">37</a> abdominal surgery,<a class="elsevierStyleCrossRef" href="#bib0065">13</a> laparoscopic sleeve gastrectomy<a class="elsevierStyleCrossRef" href="#bib0190">38</a> and lumbar disc surgery.<a class="elsevierStyleCrossRef" href="#bib0195">39</a>In this study, intravenous ibuprofen was associated with a significantly lower incidence of early postoperative fever than ketorolac. The incidence of early postoperative fever after pediatric surgery is 30.6%.<a class="elsevierStyleCrossRef" href="#bib0200">40</a> In our study, the incidence of postoperative fever in patients who received ibuprofen and ketorolac was 3% and 20% respectively. Ibuprofen and paracetamol are the most commonly used drugs to control fever in children.Pain at the site of injection of ibuprofen occurred in 3 participants and was not observed with ketorolac injection. To reduce this type of pain, we diluted ibuprofen in 50ml saline 0.9%, chose a relatively large vein for drug infusion, and infused ibuprofen over more than 15min.We found a similar incidence of gastrointestinal adverse effects, vomiting and epigastric pain in intravenous ibuprofen and ketorolac injection. In this study, the administration of both ibuprofen and ketorolac was limited to the immediate postoperative period, and this short-term use of NSAIDs is unlikely to cause systemic adverse effects.This study had some limitations. Firstly, study subjects underwent different types of surgery, a factor that could have affected the severity of postoperative pain and the results of the study. To minimize this effect, we recruited patients with similar postoperative pain severity who underwent unilateral lower abdominal open surgeries. Secondly, the incidence of injection site pain was influenced by the size of the available peripheral vein. We tried to avoid this effect by choosing the largest available vein for drug infusion. Finally, we were unable to accurately determine the incidence of intravenous ibuprofen adverse effects due to our small sample size, our single center design, and the short duration of ibuprofen administration.ConclusionIn conclusion, intravenous ibuprofen is non-inferior to ketorolac in providing postoperative analgesia measured by morphine consumption and pain scores in the immediate postoperative period in children undergoing unilateral lower abdominal surgery. The short-term intravenous injection of both drugs provides safe, effective postoperative analgesia. Intravenous ibuprofen is associated with a lower incidence of postoperative fever.Financial support and sponsorshipNone declared.Conflicts of interestNone declared." "textoCompletoSecciones" => array:1 [ "secciones" => array:14 [ 0 => array:3 [ "identificador" => "xres1776675" "titulo" => "Highlights" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:3 [ "identificador" => "xres1776677" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusions" ] ] ] 2 => array:2 [ "identificador" => "xpalclavsec1560079" "titulo" => "Keywords" ] 3 => array:3 [ "identificador" => "xres1776676" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0030" "titulo" => "Antecedentes" ] 1 => array:2 [ "identificador" => "abst0035" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0040" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0045" "titulo" => "Conclusiones" ] ] ] 4 => array:2 [ "identificador" => "xpalclavsec1560078" "titulo" => "Palabras clave" ] 5 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 6 => array:3 [ "identificador" => "sec0010" "titulo" => "Materials and methods" "secciones" => array:7 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Ethics and study design" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Randomization and blinding" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Anesthetic management" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Interventions" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Postoperative care" ] 5 => array:2 [ "identificador" => "sec0040" "titulo" => "Data collection" ] 6 => array:2 [ "identificador" => "sec0045" "titulo" => "Sample size and statistical analysis" ] ] ] 7 => array:3 [ "identificador" => "sec0050" "titulo" => "Results" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0055" "titulo" => "Drug related side effects and postoperative fever" ] ] ] 8 => array:2 [ "identificador" => "sec0060" "titulo" => "Discussion" ] 9 => array:2 [ "identificador" => "sec0065" "titulo" => "Conclusion" ] 10 => array:2 [ "identificador" => "sec0070" "titulo" => "Financial support and sponsorship" ] 11 => array:2 [ "identificador" => "sec0075" "titulo" => "Conflicts of interest" ] 12 => array:2 [ "identificador" => "xack627841" "titulo" => "Acknowledgements" ] 13 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2021-08-25" "fechaAceptado" => "2021-12-04" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1560079" "palabras" => array:5 [ 0 => "Intravenous ibuprofen" 1 => "Children" 2 => "Ketorolac" 3 => "Abdominal surgery" 4 => "Postoperative analgesia" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1560078" "palabras" => array:5 [ 0 => "Ibuprofeno intravenoso" 1 => "Niños" 2 => "Ketorolaco" 3 => "Cirugía abdominal" 4 => "Analgesia postoperatoria" ] ] ] ] "tieneResumen" => true "highlights" => array:2 [ "titulo" => "Highlights" "resumen" => "<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">•NSAIDs are used as primary analgesics or as part of multimodal analgesia to control postoperative pain.</li><li class="elsevierStyleListItem" id="lsti0010">•Intravenous ibuprofen was approved only in 2009 to control fever and pain.</li><li class="elsevierStyleListItem" id="lsti0015">•In adults, the use of intravenous ibuprofen for postoperative analgesia is safe and effective.</li><li class="elsevierStyleListItem" id="lsti0020">•Intravenous ibuprofen can be used as an alternative to ketorolac for postoperative analgesia in children.</li><li class="elsevierStyleListItem" id="lsti0025">•Intravenous ibuprofen and ketorolac provide safe and effective analgesia after pediatric lower abdominal surgery.</li></ul>" ] "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "BackgroundNon-steroidal anti-inflammatory drugs are often used as part of multimodal analgesia to control postoperative pain. This randomized, controlled, double-blinded, non-inferiority study aimed to compare the postoperative analgesic effects of intravenous ibuprofen versus ketorolac in children undergoing open unilateral lower abdominal surgery. The authors hypothesized that postoperative analgesia produced by intravenous ibuprofen would be non-inferior to that of intravenous ketorolac. MethodsSixty-six children aged 2 to 8 years who were scheduled to undergo unilateral lower abdominal surgery, were recruited. Patients in the ibuprofen group received 10mg/kg/6h intravenous ibuprofen. Patients in the ketorolac group were given 0.5mg/kg/6h intravenous ketorolac. The primary outcome measure was 24-h postoperative morphine consumption. The secondary outcome measures were postoperative pain score, the incidence of early postoperative fever and the incidence of ibuprofen and ketorolac adverse effects including pain during drug infusion, vomiting, epigastric pain and allergic reaction. ResultsFifty-nine patients completed the study (30 ibuprofen, 29 ketorolac). There was no significant difference (P=0.305) in the mean (SD) 24-h postoperative morphine consumption (μ/kg) between intravenous ibuprofen, 16.00 (5.31), and ketorolac, 14.65 (4.61). The reported pain scores were similar in both groups. The incidence of postoperative fever was significantly lower (p=0.039) in the ibuprofen group (3%) than the ketorolac group (20%). The incidence of adverse effects was similar in both ibuprofen and ketorolac groups. ConclusionsIntravenous ibuprofen can be used as an alternative to ketorolac for postoperative analgesia in children undergoing unilateral lower abdominal surgery because both drugs similarly provide safe and effective postoperative analgesia." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0010" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0015" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0020" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0025" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "AntecedentesA menudo se utilizan antiinflamatorios no esteroideos para analgesia multimodal, para controlar el dolor postoperatorio. El objetivo de este estudio aleatorio, controlado, doble ciego y de no inferioridad fue comparar los efectos analgésicos postoperatorios de ibuprofeno y ketorolaco intravenosos en niños sometidos a cirugía unilateral abierta de la zona inferior del abdomen. Los autores supusieron que la analgesia postoperatoria producida por ibuprofeno intravenoso no sería inferior a la de ketorolaco intravenoso. MétodosSesenta y seis niños de 2 a 8 años de edad fueron programados para cirugía unilateral de la zona inferior del abdomen. Los pacientes del grupo ibuprofeno recibieron 10mg/kg/6h de ibuprofeno intravenoso, y los pacientes del grupo ketorolaco recibieron 0,5mg/kg/6h de ketorolaco por vía intravenosa. La medida del objetivo primario fue el consumo morfina postoperatoria durante 24h de. Las medidas del resultado secundario fueron la puntuación del dolor postoperatorio, la incidencia de fiebre postoperatoria temprana y la incidencia de efectos adversos relativos a ibuprofeno y ketorolaco incluyendo dolor durante la infusión del fármaco, vómitos, dolor epigástrico y reacción alérgica. ResultadosCincuenta y nueve pacientes completaron el estudio (30 de ibuprofeno y 29 de ketorolaco). No se produjo diferencia significativa (P=0,305) en cuanto a consumo medio (DE) de morfina postoperatoria durante 24h (μ/kg) entre el grupo ibuprofeno, 160 (5,31),y el grupo ketorolaco, 14,65 (4,61). Las puntuaciones de dolor reportadas fueron similares en ambos grupos. La incidencia de fiebre postoperatoria fue significativamente menor (p=0,039) en el grupo ibuprofeno (3%) que en el grupo ketorolaco (20%). La incidencia de efectos adversos fue similar en ambos grupos. ConclusionesIbuprofeno intravenoso puede utilizarse como alternativa a ketorolaco para analgesia postoperatoria en niños sometidos a cirugía unilateral de la zona inferior del abdomen, ya que ambos fármacos aportan analgesia postoperatoria segura, efectiva y similar." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0030" "titulo" => "Antecedentes" ] 1 => array:2 [ "identificador" => "abst0035" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0040" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0045" "titulo" => "Conclusiones" ] ] ] ] "multimedia" => array:6 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2249 "Ancho" => 2508 "Tamanyo" => 323660 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "CONSORT Flow Diagram." ] ] 1 => array:8 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1475 "Ancho" => 2508 "Tamanyo" => 170665 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0020" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Distribution of the first rescue dose of morphine. PACU: Post anesthesia care unit." ] ] 2 => array:8 [ "identificador" => "fig0015" "etiqueta" => "Fig. 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 1891 "Ancho" => 2175 "Tamanyo" => 234860 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0025" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "Postoperative modified Children’s Hospital of Eastern Ontario Pain Scale (mCHEOPS)." ] ] 3 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0030" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Data are presented as median (IQR) and number (n) and proportion (%)." "tablatextoimagen" => array:1 [ 0 => array:1 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Variable \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ibuprofen group (n=30) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ketorolac group (n=29) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">P -value \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Age, year (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.2 (3–5.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4.5 (2.5–6.2) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.331 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Sex, M/F (n&%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">27/3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">25/4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.652 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Weight, kg (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">15 (14–18.25) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16 (13.75–20.50) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.397 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">ASA, I/II (n) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">28/2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">26/3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.612 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Type of surgery, (n&%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Herniotomy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">20(66.7%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">19(65.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.656 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Orchiopexy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5(16.7%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">7(24.1%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hydrocelectomy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5(16.7%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3(10.3%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Duration of surgery, min (IQR) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">30 (28–32.25) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">30 (28–37.50) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.464 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] ] ] ] "descripcion" => array:1 [ "en" => "Patient characteristics and types of surgery." ] ] 4 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0035" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "Data are presented as mean (SD) and median (IQR)." "tablatextoimagen" => array:1 [ 0 => array:1 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Variable \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ibuprofen group (n=30) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ketorolac group (n=29) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">P -value \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Time to first rescue analgesia, h (SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.70 (1.44) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.93 (1.48) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.547 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Number of morphine doses \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.20 (1.06) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2.93 (0.92) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.305 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Morphine consumption, μg/kg/24h (SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16.00 (5.31) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">14.65 (4.61) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.305 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Parent satisfaction score \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8.5 (7-9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">8 (8-9) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.516 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] ] ] ] "descripcion" => array:1 [ "en" => "Postoperative analgesic characteristics and parent satisfaction score." ] ] 5 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0040" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:3 [ "leyenda" => "Data are presented as number (n) and percentage (%)." "tablatextoimagen" => array:1 [ 0 => array:1 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Variable (n&%) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ibuprofen group (n=30) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ketorolac group (n=29) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">P -value \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Fever \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1/30(3%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6/29(20%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.039<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Vomiting \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2/30(6.6%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5/29(17.2%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.198 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Epigastric pain \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3/30(10%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6/29(20.6%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.219 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Pain at injection site \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3/30(10%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0/29(0%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.080 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "*" "nota" => "P<0.05 is statistically significant." ] ] ] "descripcion" => array:1 [ "en" => "Drug-related side effects and postoperative fever." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:40 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A systematic review and meta-analysis of caudal blockade versus alternative analgesic strategies for pediatric inguinal hernia repair" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "R. 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Comparison of intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery: A randomized, controlled, non-inferiority study

Comparación de ibuprofeno y ketorolaco intravenosos para analgesia postoperatoria en niños tratados mediante cirugía de la zona inferior del abdomen: estudio aleatorio, controlado y de no inferioridad

I. Abdelbaser

Corresponding author

ibraheem2005@mans.edu.eg

Corresponding author.

, N.A. Mageed, E.-S.M. El-Emam, M.M ALseoudy

Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt

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    "titulo" => "Comparison of intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery&#58; A randomized&#44; controlled&#44; non-inferiority study"
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        "titulo" => "Comparaci&#243;n de ibuprofeno y ketorolaco intravenosos para analgesia postoperatoria en ni&#241;os tratados mediante cirug&#237;a de la zona inferior del abdomen&#58; estudio aleatorio&#44; controlado y de no inferioridad"
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Distribution of the first rescue dose of morphine&#46; PACU&#58; Post anesthesia care unit&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Introduction</span><p id="par0030" class="elsevierStylePara elsevierViewall">Lower abdominal surgeries are common procedures in the pediatric population&#44; and are associated with mild to moderate postoperative pain&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> In day surgery&#44; guidelines recommend using adequate opioid-free postoperative analgesia&#46; Opioids are potent analgesics&#44; but their use can be associated with nausea&#44; vomiting&#44; pruritus&#44; respiratory depression&#44; urine retention and delayed discharge from the hospital&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">Non-steroidal anti-inflammatory drugs &#40;NSAIDs&#41; are often used in multimodal analgesia and can alleviate mild to moderate postoperative pain in pediatric patients&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> The use of NSAIDs for postoperative analgesia avoids or reduces the need for opioids&#46;<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4&#44;5</span></a> Parenterally administered NSAIDs for postoperative analgesia include ketorolac&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> diclofenac&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> piroxicam<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> and ibuprofen&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Intravenous ketorolac has been used for postoperative analgesia&#44; and its analgesic efficacy is comparable to that of morphine&#46; However&#44; given the serious adverse effects associated with ketorolac&#44; including increased intraoperative and postoperative bleeding&#44; gastritis&#44; gastric ulcer&#44; and renal dysfunction&#44; this drug needs to be replaced by other types of non-opioid analgesics&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;11</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Intravenous ibuprofen was only approved in 2009 to control fever and pain&#44;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> and is a safe&#44; effective postoperative analgesic in adults&#46;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13&#8211;15</span></a> Ibuprofen is associated with fewer gastric&#44; cardiac&#44; renal&#44; hepatic and bleeding side effects than ketorolac due to its more favorable cyclo-oxygenase-1 &#40;COX-1&#41;&#58; cyclooxygenase-2 &#40;COX-2&#41; inhibition ratio&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">Only 2 recent studies used intravenous ibuprofen for postoperative analgesia in pediatric patients - one study after tonsillectomy<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> and the other after laparoscopic hernia repair&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> To the best of our knowledge&#44; this is the first randomized clinical trial to use intravenous ibuprofen for postoperative analgesia in children undergoing open lower abdominal surgery&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">This aim of this randomized&#44; controlled&#44; non-inferiority study is to compare the postoperative analgesic effects of intravenous ibuprofen versus ketorolac in children undergoing open unilateral lower abdominal surgery&#46; We hypothesized that the quality of postoperative analgesia achieved with intravenous ibuprofen would be non-inferior to that of intravenous ketorolac&#46; The primary outcome was postoperative opioid consumption during the immediate postoperative period &#40;24<span class="elsevierStyleHsp" style=""></span>hours&#41;&#44; and the secondary outcomes were postoperative pain scores&#44; incidence of postoperative fever&#44; and adverse effects associated with intravenous ibuprofen and ketorolac&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Materials and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Ethics and study design</span><p id="par0060" class="elsevierStylePara elsevierViewall">This is a prospective&#44; single-center&#44; randomized&#44; double-blind&#44; non-inferiority&#44; controlled study with two parallel arms&#46; Approval was obtained from the institutional review board of our faculty of medicine &#40;IRB code&#58; R 20&#46;12&#46; 1129&#41; on December 24&#44; 2020&#44; before the start of patient recruitment&#46; The study protocol was registered at pan African clinical trial registry &#40;PACTR202101661828558&#41; prior to patient enrollment&#46; The study has been conducted following the ethical principles of the Declaration of Helsinki&#44; and complies with good clinical practice guidelines&#46; Written consent was obtained from the parents or legal guardians of all study patients&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">We conducted this study at the University Children&#39;s Hospital between December 2020 and June 2021&#46; A total of 66 children aged from 2 to 8 years with American Society of Anesthesiologists &#40;ASA&#41; Physical Status class I-II scheduled for unilateral lower abdominal surgery were recruited&#46; Patients were excluded if they had a history of hypersensitivity to NSAIDs&#44; had received NSAIDS in the 12<span class="elsevierStyleHsp" style=""></span>hours prior to surgery&#44; presented renal or hepatic dysfunction&#44; inflammatory bowel disease&#44; or a history of gastrointestinal bleeding&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Randomization and blinding</span><p id="par0070" class="elsevierStylePara elsevierViewall">The study participants were randomized to either intravenous ibuprofen or intravenous ketorolac using computer-generated random number tables to obtain 1&#58;1 patient allocation&#46; Sealed opaque envelopes containing the group assignment were delivered to the operating room on the morning of surgery&#44; and were opened after induction of anesthesia&#46; The anesthesiologist who prepared the study drugs was not involved in the study&#46; The observer who collected the data&#44; the postoperative nursing teams&#44; and the patient&#8217;s parents or legal guardians were all blinded to the study group&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Anesthetic management</span><p id="par0075" class="elsevierStylePara elsevierViewall">A standardized general anesthesia protocol was used in all patients&#44; and included 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg oral midazolam for premedication 30<span class="elsevierStyleHsp" style=""></span>min before separation from their parents or legal guardians&#46; The patients were monitored in the operating room using pulse oximetry&#44; electrocardiography&#44; non-invasive blood pressure monitor and capnography&#46; General anesthesia was induced with either inhalational sevoflurane or intravenous propofol 2<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#44; depending on the patient&#8217;s age and the accessibility of a peripheral venous line&#46; Thereafter&#44; the patient received 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg atracurium and 2<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;kg fentanyl&#44; followed by insertion of a non-cuffed endotracheal tube of appropriate size&#46; Anesthesia was maintained with 2&#37; sevoflurane delivered in an oxygen&#47;air mixture &#40;FiO2<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;5&#41; under controlled ventilation&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Interventions</span><p id="par0080" class="elsevierStylePara elsevierViewall">Each dose of the study drug&#44; ibuprofen or ketorolac&#44; was diluted in 50<span class="elsevierStyleHsp" style=""></span>ml 0&#46;9&#37; saline and was infused over 15<span class="elsevierStyleHsp" style=""></span>min through a large bore &#40;20-22 gauge&#41; venous cannula placed in the largest available peripheral vein&#46; Patients in the ibuprofen group received 10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg intravenous ibuprofen every 6<span class="elsevierStyleHsp" style=""></span>hours for 24<span class="elsevierStyleHsp" style=""></span>hours&#46; Patients in the ketorolac group were given 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg intravenous ketorolac every 6<span class="elsevierStyleHsp" style=""></span>hours for 24<span class="elsevierStyleHsp" style=""></span>hours&#46; Infusion of the first dose of ibuprofen or ketorolac was started 15<span class="elsevierStyleHsp" style=""></span>min before the end of surgery&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Postoperative care</span><p id="par0085" class="elsevierStylePara elsevierViewall">Patients were transferred to the post anesthesia care unit &#40;PACU&#41; after surgery&#44; where they stayed for 30<span class="elsevierStyleHsp" style=""></span>min&#46; Each patient was given a single intravenous dose of paracetamol 10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg on arrival at the PACU&#44; which was followed by 10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;6<span class="elsevierStyleHsp" style=""></span>h oral paracetamol syrup&#46; We used the modified Children&#8217;s Hospital of Eastern Ontario Pain Scale &#40;mCHEOPS&#41;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> to assess the severity of postoperative pain&#46; The 10 points mCHEOPS consist of 5 parameters including crying&#44; fascial expression&#44; verbal expression&#44; torso and legs&#46; Intravenous morphine 5<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;kg was given for rescue analgesic if mCHEOPS was greater than 3&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Data collection</span><p id="par0090" class="elsevierStylePara elsevierViewall">The primary outcome measure was total morphine consumption in the immediate postoperative period&#46; The secondary outcome measures were postoperative pain score &#40;mCHEOPS&#41;&#44; time to first rescue analgesia&#44; number of morphine doses&#44; parent satisfaction &#40;on a 10-point scale&#58; 0 not satisfied and 10 highly satisfied&#41;&#44; incidence of early postoperative fever&#44; and incidence of ibuprofen and ketorolac-related adverse effects&#44; including injection site pain&#44; vomiting&#44; epigastric pain&#44; bleeding and allergic reactions&#46; The pain score was assessed at the following time points&#58; in the PACU 15<span class="elsevierStyleHsp" style=""></span>min after surgery&#44; every hour during the first 4 postoperative hours&#44; every 2<span class="elsevierStyleHsp" style=""></span>hours over the following 4<span class="elsevierStyleHsp" style=""></span>hours&#44; and every 4<span class="elsevierStyleHsp" style=""></span>hours thereafter&#46; Early postoperative fever was defined as body temperature above 38<span class="elsevierStyleHsp" style=""></span>&#176;C during the first 2 postoperative days&#44; and was controlled with cold compresses&#46; Patients were actively followed over the phone by caregivers for 48<span class="elsevierStyleHsp" style=""></span>hours after hospital discharge&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Sample size and statistical analysis</span><p id="par0095" class="elsevierStylePara elsevierViewall">The sample size was calculated using PASS version 15&#46;0&#46;5 software for Windows &#40;PASS&#44; LLC&#44; Kaysville&#44; UT&#44; USA&#41;&#44; using a non-inferiority test for the difference between two means&#46; The study was designed as a non-inferiority trial&#46; The null hypothesis was that postoperative analgesia with intravenous ibuprofen would be inferior to that of intravenous ketorolac&#46; To test the alternative hypothesis of non-inferiority of intravenous ibuprofen compared to ketorolac&#44; the sample size was calculated on the basis of the mean total morphine consumption in the immediate postoperative period&#46; Considering the results of our preliminary study that included 5 patients in each group&#44; the mean &#40;standard deviation&#41; morphine consumption was 18 &#40;8&#46;3&#41; &#956;g&#47;kg&#47;24<span class="elsevierStyleHsp" style=""></span>h in the intravenous ibuprofen group and 17 &#40;7&#46;5&#41; &#956;g&#47;kg&#47;24<span class="elsevierStyleHsp" style=""></span>h in the ketorolac group&#46; The sample size per group of 26 patients achieved 80&#37; power to detect non-inferiority using a one-sided&#44; two-sample t-test&#46; The margin of non-inferiority was 4&#46;5<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;kg&#47;24<span class="elsevierStyleHsp" style=""></span>h&#46; The true difference between the means was assumed to be 1<span class="elsevierStyleHsp" style=""></span>&#956;g&#47;kg&#47;24<span class="elsevierStyleHsp" style=""></span>h&#46; The significance level &#40;alpha&#41; of the test was 0&#46;050&#46; The data were drawn from populations with standard deviations of 8&#46;3 and 7&#46;5&#46; Seven patients were added to each group to compensate for drop outs&#46; Thus&#44; the final sample was 33 patients for each group&#46; The 95&#37; confidence interval &#40;3&#46;9&#41; was less than the margin of non-inferiority &#40;4&#46;5&#41;&#44; therefore non-inferiority was confirmed&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">The Shapiro&#8211;Wilk test was used to check the normality of data distribution&#46; Non-parametric variables are presented as median &#40;IQR&#41; and were tested with Mann&#8211;Whitney U test&#46; Normally distributed quantitative data were analyzed with the unpaired t-test and are expressed as mean &#40;SD&#41;&#46; Categorial variables were analyzed with the Chi-Square test&#44; and are expressed as number and percentage &#40;&#37;&#41;&#46; All variables were compared between the 2 study groups&#46; The data were analyzed using IBM SPSS 21&#46;0 &#40;IBM Corp&#46;&#44; Armonk&#44; NY&#44; USA&#41; for Windows&#46; Statistical significance was p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05&#46;</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Results</span><p id="par0105" class="elsevierStylePara elsevierViewall">Sixty-six patients were recruited for the study&#44; of whom 7 were excluded&#58; 4 did not meet the inclusion criteria&#44; and 3 refused to participate&#46; Fifty-nine patients completed the study&#44; 30 patients in the ibuprofen group and 29 patients in the ketorolac group &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">Patients and Surgical Characteristics</p><p id="par0115" class="elsevierStylePara elsevierViewall">There were no significant differences between the ibuprofen and ketorolac groups in terms of patient characteristics and type of surgery &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Most patients were boys &#40;boys&#44; n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>52 <span class="elsevierStyleItalic">vs</span> girls&#44; n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>7&#41;&#46; The median age &#40;IQR&#41; was 3&#46;2 &#40;3&#8211;5&#46;2&#41; years in the ibuprofen group and 4&#46;5 &#40;2&#46;5&#8211;6&#46;2&#41; years in the ketorolac group&#46; The surgical procedures were herniotomy &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>39&#41;&#44; orchiopexy &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>12&#41; and hydrocelectomy &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0120" class="elsevierStylePara elsevierViewall">Postoperative Analgesic Characteristics and Parent Satisfaction Score</p><p id="par0125" class="elsevierStylePara elsevierViewall">Mean &#40;SD&#41; immediate postoperative morphine consumption &#40;&#956;&#47;kg&#41; did not differ significantly &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;305&#41; between the ibuprofen &#40;16&#46;00 &#91;5&#46;31&#93;&#41; and ketorolac &#40;14&#46;65 &#91;4&#46;61&#93;&#41; groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table2</a>&#41;&#46; Time to first rescue analgesic &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41; did not differ significantly between groups&#46; Mean &#40;SD&#41; time to first rescue analgesic was 3&#46;70 &#40;1&#46;44&#41; h in the ibuprofen group and 3&#46;93 &#40;1&#46;48&#41; h in the ketorolac group&#44; distributed as follows&#58; in the PACU and at 1<span class="elsevierStyleHsp" style=""></span>hour &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0 in both groups&#41;&#44; at the second time point &#40;ibuprofen n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>6&#44; ketorolac n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>7&#41;&#44; at the third time point &#40;ibuprofen n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>7&#44; ketorolac n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>3&#41; at the fourth time point &#40;ibuprofen n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>6&#44; ketorolac n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>9&#41;&#44; at the fifth time point &#40;ibuprofen n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>3&#44; ketorolac n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>4&#41; and at the sixth time point &#40;ibuprofen n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#44; ketorolac n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>6&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; The mean &#40;SD&#41; number of morphine doses during the first 24 postoperative hours was similar &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;305&#41; in the ibuprofen &#40;3&#46;20 &#91;1&#46;06&#93;&#41; and ketorolac &#40;2&#46;93 &#91;0&#46;92&#93;&#41; groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; The median &#40;IQR&#41; parent satisfaction score did not differ significantly &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;516&#41; between the ibuprofen &#40;8&#46;5<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#8211;9</span></a>&#41; and ketorolac &#40;8 &#91;8-9&#93;&#41; groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0130" class="elsevierStylePara elsevierViewall">The reported postoperative pain scores &#40;mCHEOPS&#41; were similar in both the ibuprofen and ketorolac groups at all time points &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; The median pain score was between 1 and 4 with interquartile range &#40;&#91;0-3&#93; to<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#8211;5</span></a>&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Drug related side effects and postoperative fever</span><p id="par0135" class="elsevierStylePara elsevierViewall">The incidence of postoperative fever was significantly lower &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;039&#41; in the ibuprofen &#40;3&#37;&#41; compared to the ketorolac &#40;20&#37;&#41; group &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; The incidence of adverse effects&#44; injection site pain &#40;10&#37; <span class="elsevierStyleItalic">vs</span> 0&#37;&#41;&#44; epigastric pain &#40;10&#37; <span class="elsevierStyleItalic">vs</span> 20&#37;&#41;&#44; and vomiting &#40;6&#46;6&#37; <span class="elsevierStyleItalic">vs</span> 17&#37;&#41; in ibuprofen versus ketorolac was similar &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; Other NSAID side effects &#40;bleeding and allergic reactions&#41; were not reported in either group&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0140" class="elsevierStylePara elsevierViewall">In this prospective&#44; randomized&#44; non-inferiority&#44; controlled clinical trial we compared the postoperative analgesic effects of intravenous ibuprofen and ketorolac in children scheduled for open lower abdominal surgery&#46; Intravenous ibuprofen was non-inferior to ketorolac for postoperative analgesia in terms of postoperative opioid consumption and pain score over 24<span class="elsevierStyleHsp" style=""></span>hours&#46; Furthermore&#44; intravenous ibuprofen was associated with a lower incidence of postoperative fever compared with ketorolac&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">Non-steroidal anti&#8209;inflammatory drugs have been used as primary analgesics or as a component of multimodal analgesia protocols to control postoperative pain&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> The inclusion of NSAIDs in multimodal analgesia protocols after pediatric surgery reduces postoperative opioid consumption and opioid-related adverse effects&#44; such as vomiting&#44; urine retention&#44; and respiratory depression&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> NSAIDs&#44; including ibuprofen and ketorolac&#44; reversibly inhibit COX-1 and COX-2 enzymes&#44; thereby inhibiting prostaglandin H&#8322; synthesis&#44; which is a mediator of pain&#44; fever and inflammation&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> COX-1 is present in the gastrointestinal mucosa&#44; kidneys and platelets&#44; while COX-2 is expressed in muscle tissue&#44; including skeletal&#44; cardiac and smooth muscles&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> The analgesic&#44; anti-febrile and anti-inflammatory effects of NSAIDs are mediated through COX-2 inhibition&#46; The adverse effects of NSAIDs&#44; such as bleeding and gastritis&#44; are attributed to COX-1 inhibition&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> The ratio of COX-1 to COX-2 inhibition is 2&#46;5&#58;1 for ibuprofen and 330&#58;1 for ketorolac&#44; which explains the higher incidence of bleeding and gastrointestinal adverse effects of ketorolac in comparison with other non-selective COX-2 inhibitors such as ibuprofen&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a></p><p id="par0150" class="elsevierStylePara elsevierViewall">In our study&#44; we chose to compare intravenous ketorolac with intravenous ibuprofen because ketorolac has proven postoperative analgesic efficacy in both adults and pediatric patients&#46; Ketorolac has been used in children to control postoperative pain after various surgical procedures&#44; such as abdominal surgery&#44; cardiac surgery&#44; orthopedic surgery&#44; tonsillectomy&#44; trauma surgery&#44; urological surgery and ophthalmic surgery&#46;<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">24&#44;25</span></a> Saryazdi et al&#46; compared the postoperative analgesic effects of intravenous ketorolac and pethidine in pediatric patients undergoing inguinal herniotomy&#44; and found that ketorolac was superior to pethidine&#46;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> In children&#44; several studies have reported the opioid sparing effect of postoperative intravenous ketorolac&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">27&#8211;29</span></a> Many adult studies have also shown that the postoperative analgesic efficacy of ketorolac is similar to that of tramadol and other opioids&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">30&#8211;33</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">In this study&#44; intravenous ibuprofen was non-inferior to intravenous ketorolac in reducing morphine consumption and pain scores in the immediate postoperative period&#46; In line with our results&#44; Dwarica et al&#46; reported that both intravenous ketorolac and ibuprofen obtained similar reductions in postoperative hydromorphone consumption and pain scores in adults who underwent gynecological surgeries&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">34</span></a> The results of a study by Uribe et al&#46; showed that intravenous ibuprofen was superior to ketorolac in reducing postoperative opioid consumption and pain scores in adult patients who underwent arthroscopic knee surgeries&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">35</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">Oral ibuprofen is one of the most popular NSAIDs&#44; and has been prescribed for fever and pain for more than 40 years&#46; Intravenous ibuprofen was approved in 2009 for mild to moderate pain and as an adjunct to opioids in multimodal analgesia to relieve moderate to severe pain&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0165" class="elsevierStylePara elsevierViewall">To the best of our knowledge&#44; this is the first study to use intravenous ibuprofen for postoperative analgesia in children undergoing open abdominal surgery&#44; and the first to compare the postoperative analgesic efficacy of intravenous ibuprofen and ketorolac in pediatric patients&#46; In children&#44; only 3 randomized studies have been conducted to evaluate the postoperative analgesic efficacy of intravenous ibuprofen&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">16&#44;17&#44;36</span></a> A recent study by Lee et al&#46; showed that combination intravenous ibuprofen and paracetamol was superior to paracetamol alone in reducing postoperative opioid consumption in children who underwent laparoscopic inguinal hernia repair&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> Moss et al&#46; found that a single intravenous dose of ibuprofen significantly reduced postoperative fentanyl consumption in children after tonsillectomy&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Troendle et al&#46; found that the use of intravenous ibuprofen in children undergoing endoscopic retrograde cholangiopancreatography was associated with a significantly lower incidence of post-cholangiopancreatography pancreatitis and lower postoperative pain scores in comparison with placebo&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">36</span></a></p><p id="par0170" class="elsevierStylePara elsevierViewall">In adult patients&#44; several studies have showed the analgesic efficacy of postoperative intravenous ibuprofen&#46; Intravenous ibuprofen in adult patients reduces postoperative opioid consumption and pain scores following total hip replacement&#44;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">37</span></a> abdominal surgery&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> laparoscopic sleeve gastrectomy<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">38</span></a> and lumbar disc surgery&#46;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">39</span></a></p><p id="par0175" class="elsevierStylePara elsevierViewall">In this study&#44; intravenous ibuprofen was associated with a significantly lower incidence of early postoperative fever than ketorolac&#46; The incidence of early postoperative fever after pediatric surgery is 30&#46;6&#37;&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">40</span></a> In our study&#44; the incidence of postoperative fever in patients who received ibuprofen and ketorolac was 3&#37; and 20&#37; respectively&#46; Ibuprofen and paracetamol are the most commonly used drugs to control fever in children&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">Pain at the site of injection of ibuprofen occurred in 3 participants and was not observed with ketorolac injection&#46; To reduce this type of pain&#44; we diluted ibuprofen in 50<span class="elsevierStyleHsp" style=""></span>ml saline 0&#46;9&#37;&#44; chose a relatively large vein for drug infusion&#44; and infused ibuprofen over more than 15<span class="elsevierStyleHsp" style=""></span>min&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">We found a similar incidence of gastrointestinal adverse effects&#44; vomiting and epigastric pain in intravenous ibuprofen and ketorolac injection&#46; In this study&#44; the administration of both ibuprofen and ketorolac was limited to the immediate postoperative period&#44; and this short-term use of NSAIDs is unlikely to cause systemic adverse effects&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">This study had some limitations&#46; Firstly&#44; study subjects underwent different types of surgery&#44; a factor that could have affected the severity of postoperative pain and the results of the study&#46; To minimize this effect&#44; we recruited patients with similar postoperative pain severity who underwent unilateral lower abdominal open surgeries&#46; Secondly&#44; the incidence of injection site pain was influenced by the size of the available peripheral vein&#46; We tried to avoid this effect by choosing the largest available vein for drug infusion&#46; Finally&#44; we were unable to accurately determine the incidence of intravenous ibuprofen adverse effects due to our small sample size&#44; our single center design&#44; and the short duration of ibuprofen administration&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conclusion</span><p id="par0195" class="elsevierStylePara elsevierViewall">In conclusion&#44; intravenous ibuprofen is non-inferior to ketorolac in providing postoperative analgesia measured by morphine consumption and pain scores in the immediate postoperative period in children undergoing unilateral lower abdominal surgery&#46; The short-term intravenous injection of both drugs provides safe&#44; effective postoperative analgesia&#46; Intravenous ibuprofen is associated with a lower incidence of postoperative fever&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Financial support and sponsorship</span><p id="par0200" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conflicts of interest</span><p id="par0205" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span></span>"
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    "highlights" => array:2 [
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      "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0005" class="elsevierStylePara elsevierViewall">NSAIDs are used as primary analgesics or as part of multimodal analgesia to control postoperative pain&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0010" class="elsevierStylePara elsevierViewall">Intravenous ibuprofen was approved only in 2009 to control fever and pain&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0015" class="elsevierStylePara elsevierViewall">In adults&#44; the use of intravenous ibuprofen for postoperative analgesia is safe and effective&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0020" class="elsevierStylePara elsevierViewall">Intravenous ibuprofen can be used as an alternative to ketorolac for postoperative analgesia in children&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Intravenous ibuprofen and ketorolac provide safe and effective analgesia after pediatric lower abdominal surgery&#46;</p></li></ul></p></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Background</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Non-steroidal anti-inflammatory drugs are often used as part of multimodal analgesia to control postoperative pain&#46; This randomized&#44; controlled&#44; double-blinded&#44; non-inferiority study aimed to compare the postoperative analgesic effects of intravenous ibuprofen versus ketorolac in children undergoing open unilateral lower abdominal surgery&#46; The authors hypothesized that postoperative analgesia produced by intravenous ibuprofen would be non-inferior to that of intravenous ketorolac&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Methods</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Sixty-six children aged 2 to 8 years who were scheduled to undergo unilateral lower abdominal surgery&#44; were recruited&#46; Patients in the ibuprofen group received 10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;6<span class="elsevierStyleHsp" style=""></span>h intravenous ibuprofen&#46; Patients in the ketorolac group were given 0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;6<span class="elsevierStyleHsp" style=""></span>h intravenous ketorolac&#46; The primary outcome measure was 24-h postoperative morphine consumption&#46; The secondary outcome measures were postoperative pain score&#44; the incidence of early postoperative fever and the incidence of ibuprofen and ketorolac adverse effects including pain during drug infusion&#44; vomiting&#44; epigastric pain and allergic reaction&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Results</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Fifty-nine patients completed the study &#40;30 ibuprofen&#44; 29 ketorolac&#41;&#46; There was no significant difference &#40;P<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;305&#41; in the mean &#40;SD&#41; 24-h postoperative morphine consumption &#40;&#956;&#47;kg&#41; between intravenous ibuprofen&#44; 16&#46;00 &#40;5&#46;31&#41;&#44; and ketorolac&#44; 14&#46;65 &#40;4&#46;61&#41;&#46; The reported pain scores were similar in both groups&#46; The incidence of postoperative fever was significantly lower &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;039&#41; in the ibuprofen group &#40;3&#37;&#41; than the ketorolac group &#40;20&#37;&#41;&#46; The incidence of adverse effects was similar in both ibuprofen and ketorolac groups&#46;</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusions</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Intravenous ibuprofen can be used as an alternative to ketorolac for postoperative analgesia in children undergoing unilateral lower abdominal surgery because both drugs similarly provide safe and effective postoperative analgesia&#46;</p></span>"
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        "resumen" => "<span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Antecedentes</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">A menudo se utilizan antiinflamatorios no esteroideos para analgesia multimodal&#44; para controlar el dolor postoperatorio&#46; El objetivo de este estudio aleatorio&#44; controlado&#44; doble ciego y de no inferioridad fue comparar los efectos analg&#233;sicos postoperatorios de ibuprofeno y ketorolaco intravenosos en ni&#241;os sometidos a cirug&#237;a unilateral abierta de la zona inferior del abdomen&#46; Los autores supusieron que la analgesia postoperatoria producida por ibuprofeno intravenoso no ser&#237;a inferior a la de ketorolaco intravenoso&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">M&#233;todos</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Sesenta y seis ni&#241;os de 2 a 8 a&#241;os de edad fueron programados para cirug&#237;a unilateral de la zona inferior del abdomen&#46; Los pacientes del grupo ibuprofeno recibieron 10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;6<span class="elsevierStyleHsp" style=""></span>h de ibuprofeno intravenoso&#44; y los pacientes del grupo ketorolaco recibieron 0&#44;5<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;6<span class="elsevierStyleHsp" style=""></span>h de ketorolaco por v&#237;a intravenosa&#46; La medida del objetivo primario fue el consumo morfina postoperatoria durante 24<span class="elsevierStyleHsp" style=""></span>h de&#46; Las medidas del resultado secundario fueron la puntuaci&#243;n del dolor postoperatorio&#44; la incidencia de fiebre postoperatoria temprana y la incidencia de efectos adversos relativos a ibuprofeno y ketorolaco incluyendo dolor durante la infusi&#243;n del f&#225;rmaco&#44; v&#243;mitos&#44; dolor epig&#225;strico y reacci&#243;n al&#233;rgica&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Resultados</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">Cincuenta y nueve pacientes completaron el estudio &#40;30 de ibuprofeno y 29 de ketorolaco&#41;&#46; No se produjo diferencia significativa &#40;P<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;305&#41; en cuanto a consumo medio &#40;DE&#41; de morfina postoperatoria durante 24<span class="elsevierStyleHsp" style=""></span>h &#40;&#956;&#47;kg&#41; entre el grupo ibuprofeno&#44; 160 &#40;5&#44;31&#41;&#44;y el grupo ketorolaco&#44; 14&#44;65 &#40;4&#44;61&#41;&#46; Las puntuaciones de dolor reportadas fueron similares en ambos grupos&#46; La incidencia de fiebre postoperatoria fue significativamente menor &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;039&#41; en el grupo ibuprofeno &#40;3&#37;&#41; que en el grupo ketorolaco &#40;20&#37;&#41;&#46; La incidencia de efectos adversos fue similar en ambos grupos&#46;</p></span> <span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conclusiones</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Ibuprofeno intravenoso puede utilizarse como alternativa a ketorolaco para analgesia postoperatoria en ni&#241;os sometidos a cirug&#237;a unilateral de la zona inferior del abdomen&#44; ya que ambos f&#225;rmacos aportan analgesia postoperatoria segura&#44; efectiva y similar&#46;</p></span>"
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">25&#47;4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">26&#47;3&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;612&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">20&#40;66&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">19&#40;65&#46;5&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;656&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">5&#40;16&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">7&#40;24&#46;1&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ibuprofen group &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>30&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Ketorolac group &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>29&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">P -value&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Time to first rescue analgesia&#44; h &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">3&#46;70 &#40;1&#46;44&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">3&#46;93 &#40;1&#46;48&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">0&#46;547&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Number of morphine doses&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">3&#46;20 &#40;1&#46;06&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">2&#46;93 &#40;0&#46;92&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;305&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Morphine consumption&#44; &#956;g&#47;kg&#47;24<span class="elsevierStyleHsp" style=""></span>h &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">16&#46;00 &#40;5&#46;31&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">14&#46;65 &#40;4&#46;61&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&#46;305&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">Parent satisfaction score&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&#46;5 &#40;7-9&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8 &#40;8-9&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">0&#46;516&nbsp;\t\t\t\t\t\t\n
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                    0 => array:2 [
                      "titulo" => "A systematic review and meta-analysis of caudal blockade versus alternative analgesic strategies for pediatric inguinal hernia repair"
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                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "R&#46; Baird"
                            1 => "M&#46;P&#46; Guilbault"
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                      "doi" => "10.1016/j.jpedsurg.2013.02.030"
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                        "volumen" => "48"
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                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/23701786"
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                            0 => "S&#46;M&#46; Walker"
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                      "doi" => "10.1097/ACO.0000000000000227"
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                        "tituloSerie" => "Curr Opin Anaesthesiol&#46;"
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                          "etal" => false
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                            0 => "E&#46;D&#46; McNicol"
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                            2 => "T&#46;E&#46; Cooper"
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