{"paper_id":"9442ebe1-0216-4830-9148-ec080b6858e1","body_text":"International Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gyn ecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \n \n \n \nA Comparison of the Efficacy of Dexamethasone \nand Ketorolac in Preventing Postoperative Pain and \nSide-effects in Gynecologic Laparoscopic Surgeries: \nA Double-blind Randomized Clinical Trial \nZahra Asgari(MD)1, Bahareh Meybodi(MD)1*, Masoumeh Nataj Majd(MD)2, \nReyhaneh Hosseini(MD)1, Farahnaz Hajibeygi(BSc)1 \n \n1 Department of Gynecology, School of Medicine, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran. \n2 Department of Anesthesiology, School of Medicine, Arash Hospital, Tehran University of Medical Sciences, Tehran, \nIran. \nABSTRACT \nBackground: The impact of preoperative administration of dexamethasone and ketorolac on postoperative \nanalgesia and side-effects of laparoscopic surgeries is acknowledged. However, the efficacy of dexamethason e \nversus ketorolac has not been compared in any earlier investigations, which was the main goal of this study. \nMethods: In a randomized, double-blind placebo control study, 114 females who were elected for  minor \nlaparoscopic surgeries were randomly allocated into the three study groups: 30 mg preoperative intravenous \nketorolac, 8 mg preoperative intravenous dexamethasone, and preoperative placebo ( normal saline). \nPostoperative pain was evaluated at 1h, 6h, 12h, and 24h after the laparoscopy using the Visual Analog Scale \n(VAS) for pain. Postoperative opioid consumption and the occurrence of nausea and vomiting were also \nrecorded.   \nResults: Characteristic features of the study groups were similar. In comparison with the placebo group, \npostoperative pain over time and opioid consumption were significantly lower in the dexamethasone (p<0.001 \nand p=0.02, respectively) and ketorolac group (p<0.001 and p=0.002, respectively), while the occurrence of \nnausea and vomiting was significantly lower only in the dexamethasone group (p=0.03 for both). In comparison \nwith the dexamethasone group, early postoperative pain was lower in the ketorolac group (p=0.01), while the \nincidence of postoperative nausea and vomiting was significantly smaller in the dexamethasone group \n(p=0.045 and p=0.03). The opioid usage was not significantly different between the dexamet hasone and the \nketorolac group (p=0.3). \nConclusion: In minor laparoscopic surgeries, preoperative ketorolac is more efficacious for postoperative pain \ncontrol, and dexamethasone can be used for patients in whom postoperative control of nausea and vomiting is \na priority. \nKey Words: Laparoscopy, Dexamethasone, Ketorolac, Pain. \n eIJPPR 2020; 10(5):226-231 \nHOW TO CITE THIS ARTICLE: Zahra Asgari, Bahareh Meybodi, Masoumeh Nataj Majd, Reyhaneh Hosseini, Farahnaz Hajibeygi (2020). \n“A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic Laparoscopic \nSurgeries: A Double-blind Randomized Clinical Trial ”, International Journal of Pharmaceutical and Phyto pharmacological Research, 10(5), \npp.226-231. \n \nINTRODUCTION \nLaparoscopy is a minimally invasive surgery that contains \nseveral advantages in comparison with open procedures, \nincluding earlier regain of bowel function, lower \npostoperative pain, sooner recovery, and less hospital stay \n[1]. Although the extent of pain has significantly \ndecreased following the implication of laparoscopy \ntechniques, the postoperative pain and its effect on the \nrecovery of the patients remains a remarkable concern. In \n   Corresponding author: Bahareh Meybodi \n   Address: Arash Women Hospital, Corner of 162 Alley (Shahid Abdolmajid), Next to Police Station 126, Shahid Baghdarnia Street (North \nRashid), After Shahid Bagheri Highway, Resalat Highway. \nE-mail:  meybodi12541 @ gmail.com \nRelevant conflicts of interest/financial disclosures:  The authors declare that the research was conducted in the absence of any \ncommercial or financial relationships that could be construed as a potential conflict of interest .  \nReceived: 28 June 2020; Revised: 18 October 2020; Accepted: 23 October 2020 \n\nInternational Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \naddition to the pain at the sites of the incisional and trocar \ninsertion, shoulder and diffuse abdominal pain caused by \nperitoneal stretching and diaphragmatic irritation could \ndelay the recovery of patients, leading to more \nhospitalization and increased financial burden on both the \npatients and healthcare systems [2]. Therefore, effective \npain management after the laparoscopic procedure is of \ncritical importance. \nDespite numerous studies on pain management after \nlaparoscopy, there is still no consensus on several aspects \nof this field, including the timing, route, dose, and type of \nthe analgesic administration [3]. Concerning the type of \nanalgesic drugs, a wide range of medications, including \nNonsteroidal Anti-Inflammatory Drugs (NSAIDs), \nopioids, and corticosteroids, are being used for post-\nlaparoscopic pain management [3]. Even so, there is no \nagreement on the optimal choice of analgesic drugs for \npain relief after laparoscopy [3]. \nCorticosteroids have long been used to decrease \ninflammatory response and postoperative pain in various \nsurgeries. Dexamethasone, as a widely used \ncorticosteroid, is considered a powerful anti-inflammatory \ndrug that may also prevent postoperative nausea and \nvomiting. The efficacy of dexamethasone in laparoscopic \npain management has been demonstrated in many \ninvestigations [4, 5]. Ketorolac is an NSAID that is \ncommonly used for short-term moderate to severe \npainkilling in various conditions such as post-surgical \npain [6]. The efficacy of ketorolac for pain management \nafter laparoscopy has been also investigated in several \ninvestigations [7-9]. \nAs far as we are informed, no study has been carried out \nto compare the analgesic effects of dexamethasone with \nketorolac for pain relief after laparoscopy. In this \nrandomized clinical trial study, we aimed to compare the \nanalgesic impacts of a single-dose of preoperative \nintravenous dexamethasone versus ketorolac in patients \nwho undergo minor gynecologic laparoscopic surgeries. \nPATIENTS AND METHODS \nThis randomized controlled trial was confirmed by the \nethics committee of our university under the code of \nIR.TUMS.Medicine.REC.1398.9412. The protocol of the \nstudy was registered in the Iranian Registry of Clinical \nTrials under the code of IRCT20110530006640N7. \nWritten informed consent was obtained from the patients \nbefore their participation in the study. All the procedures \nwere carried out by the ethical standards of the \nresponsible committee on human experimentation \n(institutional or regional) and with the Helsinki \nDeclaration of 1975, as revised in 2000 (available at \nhttp://www.wma.net/e/policy/17-c_e.html). \nBetween January 2019 and March 2020, women who \nwere elected for minor gynecologic laparoscopic \nsurgeries (diagnostic laparoscopy, cystectomy, \nsalpingectomy, oophorectomy, and tubectomy) were \nevaluated for the study eligibility criteria. Inclusion \ncriteria were the age of 18-65 years, body mass index <30 \nkg/m2, and American Society of Anesthesiologists (ASA) \ngrade I or II. Exclusion criteria were allergy to analgesics, \nanticoagulant consumption during the last four weeks, \ndaily intake of opioids or anti-anxiety medications, fever, \nor bacterial infection within the last two weeks (Figure 1).\n \n \nFigure 1: Flow Diagram of the Study Inclusion and Exclusion \n\n\nInternational Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \nIntervention \nPatients who met the criteria of the study were randomly \nassigned to the three study groups. The first group \nreceived 30 mg intravenous ketorolac (15 mg/ml, 2 ml). \nThe second group received 8 mg intravenous \ndexamethasone (4 mg/ml, 2 ml).  The third group \n(placebo group) received 2 ml intravenous normal saline. \nAll the injection was performed 30 min before the \nlaparoscopy. All patients received similar anesthesia \n(general anesthesia with intubation). \nRandomization and Blinding \nRandomization was done using a computer-generated list. \nFor this purpose, 114 sealed envelopes were numbered 1-\n114 according to the randomization list. The \nrandomization codes were kept separate until the stud y \nwas completed. The randomization ratio was 1: 1, with 38 \nenvelopes allocated to each group distributed in parallel \ntrial design. A nurse that was not involved in the study \nopened a sealed envelope in a closed medicine room 30 –\n60 min before the operation. The analgesics or placebo \nwere drawn into a 2-ml syringe and intravenously injected \ninto the participants. All solutions were transparent and \nvisually similar. Therefore, both injector and recipients \nwere kept blinded to the group allocation. \nOutcome Measures \nThe primary outcome measure was postoperative overall \npain (incisional, visceral, and shoulder pain) that was \nassessed using the visual analog scale for pain at 1, 6, 12, \nand 24 hours after the operation. Accordingly, the pain \nranged from 0 (no pain) to 10 (most severe pain). The \nsecondary outcome measures were the number of \npostoperative opioid consumption and the incidence of \nPostoperative Nausea and Vomiting (PONV) within 24 h \nafter the surgery. \nSample Size Calculation and Statistical Analysis \nThe sample size was calculated using the Standard \nDeviation (SD) of 2.23 for VAS provided in the study of \nZangoue et al. [10]. According to this SD, an effect size \nof 1.5, power of  80%, a significance level of 5%, and \nconsidering 10% dropouts, many 38 patients were \nincluded in each group of study. \nSPSS for Windows, version 16 (Chicago, Illinois, USA) \nwas applied for all statistical analyses. Qualitative \nvariables were demonstrated by number and percentage. \nQuantitative data were presented as mean ± SD. A One-\nway-ANOVA test was used to compare the characteristic \nfeatures of the three study groups. Repeated measure \nAnalysis of Variance (ANOVA) was used to compare \npain between the groups over time. Qualitative variables \nwere compared with a Chi-square test. The line charts \nwere demonstrated with Microsoft Excel 2010. A p-value \nof ≤ 0.05 was considered statistically significant.  \nRESULTS \nDemographic  Characteristics \nOne hundred fourteen patients who underwent minor \nlaparoscopic surgery were randomly divided into three \nstudy groups. The study populations were females with a \nmean age of 44.2±11.3 years (Range 23-62). Diagnostic \nlaparoscopy was the most common laparoscopy \nprocedure (n=56, 49.1%) followed by tubectomy (n=24, \n21%). No significant difference was observed between \nthe characteristics features of the three study groups \n(Table 1). \nTable 1: Comparison of Characteristic Features between Three Study Groups \nVariable Ketorolac Group \n(n=38) \nDexamethasone Group \n(n=38) \nPlacebo Group \n(n=38) P Value \nAge (Year) 43.9±11.2 44.1±10.9 44.4±11.6 0.61 \nBody Mass Index (kg/m2) 25.1±4.1 24.8±3.8 24.6±3.6 0.73 \nASA Type \n• I \n• II \n \n31 (81.6) \n7 (18.4) \n \n33 (86.8) \n5 (13.2) \n \n32 (84.2) \n6 (15.6) \n0.54 \nLaparoscopy Procedure \n• Diagnostic \n• Tubectomy \n• Oophorectomy \n• Cystectomy \n• Salpingectomy \n \n19 (50) \n8 (21) \n4 (10.5) \n4 (10.5) \n3 (8) \n \n17 (44.6) \n10 (26.3) \n5 (13.1) \n3 (8) \n3 (8) \n \n20 (52.6) \n6 (15.8) \n5 (13.1) \n4 (10.5) \n3 (8) \n0.44 \nSurgery Duration (min) 66.2±12.6 68.3±14.2 65.4±13.1 0.39 \nData are presented as mean±SD or number (%). P<0.05 is considered significant. \n \nComparison of Outcome Measures between \nDexamethasone and Placebo Group \nThe mean VAS for pain over time  was significantly  \nsmaller in patients of the dexamethasone group compared \n\nInternational Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \nto the patients of the placebo group (p<0.001) (Figure \n2A). Opioid was administered for 47.2% (17 of 36) of the \npatients of the placebo group and 20% (7 of 35) of \npatients of the dexamethasone group (p=0.02). During the \n24 h after the laparoscopy, moderate to severe nausea was \nrecorded in 27.7% (10 of 36) of patients of the placebo \ngroup and 5.7% (2 of 35) of patients of the \ndexamethasone group (p=0.03). Vomiting was recorded \nin 22.2% (8 of 36) of the placebo group and 2.9% (1 of \n35) of patients of the dexamethasone group (p=0.03). \nComparison of Outcome Measures between Ketorolac \nand Placebo Group \nThe mean VAS for pain over time  was significantly  \nsmaller in patients of Ketorolac group compared to the \npatients of the placebo group (p<0.001) (Figure 2B). \nOpioid was administered for 47.2% (17 of 36) of the \npatients of the placebo group and 8.8% (3 of 34) of \npatients of the ketorolac group (p=0.002). During the 24 h \nafter the laparoscopy,  moderate to severe  nausea was \nrecorded in 27.7% (10 of 36) of patients of the placebo \ngroup and 23.5% (8 of 34) of patients of the ketorolac \ngroup (p=0.8). Vomiting was recorded in 22.2% (8 of 36) \nof the placebo group and 20.5% (7 of 34) of patients of \nthe ketorolac group (p=0.9). \nComparison of Outcome Measures between Ketorolac \nand Dexamethasone Group \nThe mean VAS for pain over time  was significantly  \nsmaller in patients of Ketorolac group compared to the \npatients of the dexamethasone group (p=0.01) (Figure \n2C). Opioid was administered for 20% (7 of 35) of the \npatients of the dexamethasone group and 8.8% (3 of 34) \nof patients of the ketorolac group (p=0.3). During the 24 h \nafter the laparoscopy,  moderate to severe  nausea was \nrecorded in 5.7% (2 of 35) of patients of the \ndexamethasone group and 23.5% (8 of 34) of patients of \nthe ketorolac group (p=0.045). Vomiting was recorded in \n2.9% (1 of 35) of the dexamethasone group and 20.5% (7 \nof 34) of patients of the ketorolac group (p=0.03). \n \n \n \n \nFigure 2: Comparison of VAS for pain of the different \ntime points between (A) the dexamethasone & placebo \ngroup; (B) the ketorolac & placebo group; and (C) the \nketorolac & dexamethasone group.  \nDISCUSSION \nIn the present study, we compared the efficacy of \npreoperative dexamethasone and ketorolac with each \nother as well as with placebo on the management of \npostoperative pain, opioid consumption, nausea, and \nvomiting frequency after minor laparoscopic procedures. \nAccording to our results, both dexamethasone and \nketorolac significantly reduced postoperative pain and \nopioid consumption when compared with the placebo. \nDexamethasone, but not ketorolac, significantly reduced \nthe occurrence of postoperative nausea and vomiting \nwhen compared with placebo. Dexamethasone's effect on \npain control was significantly lower than ketorolac. \nHowever, the extent of nausea and vomiting was \nsignificantly lower in the dexamethasone group compared \nto the ketorolac group. \nThe efficacy of dexamethasone on post-laparoscopic \nanalgesia and side-effects has been investigated in several \nother investigations. Yamanaga et al., in a retrospective \nstudy, evaluated the efficacy of a single perioperative \ninjection of dexamethasone on postoperative nausea, \nvomiting, and pain level of patients after laparoscopic \ndonor nephrectomy. They categorized patients into three \ngroups: low-dose dexamethasone (4-6 mg, n=70), high-\n\n\nInternational Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \ndose dexamethasone (8-14 mg, n=100), and control group \n(no analgesic, n=110). According to their report, high-\ndose dexamethasone significantly reduced the occurrence \nof postoperative nausea and vomiting compared to the \ncontrol group. Total opioid consumption was also \nsignificantly lower in donors who received the higher \ndose of dexamethasone than in control [11]. We used a \nhigh dose of dexamethasone in the present series (8 mg). \nSimilar to the study of Yamanaga et al., the occurrence of \nnausea and vomiting, as well as opioid consumption, were \nsignificantly less in the dexamethasone group than in the \ncontrol group.  \nMohtadi et al., in a prospective study, compared the \nanalgesic impact of a single dose of dexamethasone \ninjection (n=61) with the control group (n=61) on \ndecreasing postoperative pain in laparoscopic \ncholecystectomy. According to their results, postoperative \npain intensity was, and opioid consumption was \nsignificantly lower in the dexamethasone group [12]. The \nsame results were observed in the present study. \nBisgaard et al., in a randomized, double-blind placebo-\ncontrolled trial evaluated the efficacy of preoperative \ndexamethasone on the improvement of surgical outcome \nafter laparoscopic cholecystectomy. In this study, 88 \npatients were randomly allocated to either the intravenous \ndexamethasone (8 mg) or placebo group. Injections were \nperformed 90 minutes before laparoscopy. According to \ntheir results, dexamethasone significantly decreased \npostoperative \nlevels of CRP, fatigue, overall pain, incisional pain, and \nopioid consumption during the first postoperative 24 h. \nDexamethasone also significantly reduced nausea and \nvomiting on the first day after the operation [13]. We also \nobserved a significant effect of preoperative \ndexamethasone on the reduction of pain and opioid \nconsumption, as well as lowering the incidence of nausea \nand vomiting compared to the control group. \nEfficacy of preoperative dexamethasone on post-\nlaparoscopic pain and side-effects has been investigated \nin several other investigations, as well. In a systematic \nstudy and meta-analysis study, Waldron et al. investigated \nthe effect of perioperative dexamethasone administration \non postoperative analgesia and side-effects. According to \ntheir analysis, patients who received preoperative \ndexamethasone reported significantly lower pain during \nthe first 24 h after laparoscopic surgery, but preoperative \ndexamethasone revealed no significant effect on opioid \nconsumption [4]. \nThe effect of preoperative ketorolac on post-laparoscopy \nanalgesia and side-effects has also been investigated in \nsome studies. Chow et al., in a prospective, doub le-blind \ncontrolled study investigated the impact of preoperative \nketorolac administration on postoperative pain intensity in \npatients undergoing laparoscopic urologic surgery. \nAccording to their results, preoperative ketorolac \nadministration significantly reduced the subjective pain \nperception of pain and narcotic usage compared to the \ncontrol group [14]. The present study also revealed the \nsignificant impact of preoperative ketorolac on decreasing \npostoperative pain intensity and opioid consumption. \nYeon Hong studied the impact of preoperative ketorolac \non the pain intensity in patients who underwent \nlaparoscopic surgery for endometriosis. Fifty patients \nwere randomly assigned to either ketorolac (0.5 mg/kg) or \nthe control group. According to this study, total \nmeperidine dose and VAS for pain were significantly \nlower in the ketorolac group than in the control group. \nThe occurrences of postoperative side effects, such as \nnausea, were not significantly different between the \ngroups [8]. Similar to the study of Yeon Hong, \npostoperative pain was significantly lower in the \nketorolac group of the present study. Moreover, no \nsignificant difference was seen between the occurrence of \npostoperative nausea and vomiting between the ketorolac \nand the control group. \nThe positive impact of preoperative ketorolac \nadministration on post-laparoscopic pain management has \nalso been demonstrated in other investigations [15, 16] . \nHowever, as far as we are informed, no study has been \ncarried out to compare the efficacy of preparativ e \ndexamethasone versus preparative ketorolac on the \nanalgesia and side-effects of laparoscopic surgeries. \nAccording to our analysis, early postoperative pain \nintensity was significantly lower in patients who received \nketorolac, whereas the occurrence of nausea and vomiting \nwas significantly lower in the dexamethasone group. \nThese findings reveal that preoperative dexamethasone \ncould be regarded as a better option for patients who are \nat a higher risk of postoperative nausea and vomiting such \nas patients with a background of motor sickness of \nmigraine [17].  \nThe present study was not without limitations. The main \nlimitation of the study was the heterogeneous etiology of \nlaparoscopy in our patients. Although types of \nlaparoscopic surgery were not significantly different \nbetween the study groups, a more homogenous group of \npatients would better demonstrate the efficacy of \nketorolac versus dexamethasone on the improvement of \nsurgical outcomes.   \nCONCLUSIONS:  \nIn minor gynecologic laparoscopic surgeries, preoperative \nadministration of dexamethasone and ketorolac both \nreduce the postoperative pain intensity and opioid usage \ncompared to the control group. In comparison with \n\nInternational Journal of Pharmaceutical and Phytopharmacological Research (eIJPPR) | October 2020 | Volume 10| Issue 5| Page 226-231 \nZahra Asgari, A Comparison of the Efficacy of Dexamethasone and Ketorolac in Preventing Postoperative Pain and Side-effects in Gynecologic \nLaparoscopic Surgeries: A Double-blind Randomized Clinical Trial \nISSN (Online) 2249-6084 (Print) 2250-1029        \n                                                                                www.eijppr.com \n \nketorolac, preoperative dexamethasone provides better \ncontrol of nausea and vomiting and lower control of early \npostoperative pain. Therefore, dexamethasone is a better \nchoice in patients susceptible to postoperative nausea and \nvomiting. \nACKNOWLEDGMENTS:  \nNone \n \nConflict of Interest:  \nThe authors declare no conflict of interest to disclose.  \nREFERENCES \n[1] Gerges FJ, Kanazi GE, Jabbour-Khoury SI. \nAnesthesia for laparoscopy: a review. J. Clin. 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Evidence-based analysis of risk \nfactors for postoperative nausea and vomiting. Br. J. \nAnaesth. 2012;109(5):742-53.","source_license":"CC0","license_restricted":false}