Comparison of the efficacy of dexamethasone versus ketorolac on postoperative analgesia and side-effects of minor laparoscopic surgeries: a double-blinded randomized clinical trial ‎ ‎

To compare the effect of dexamethasone and ketorolac on postoperative analgesia and side-effects in minor laparoscopic surgeries

Randomized controlled clinical trial, three-arm parallel-group design of 114 patients, double-blinded. Randomization will be done by the rand function of Excel software.

Patients who are referred to the Arash Women's Hospital of Tehran University of Medical Sciences, if eligible, will be randomized into the three study groups including ketorolac, dexamethasone, and placebo. The participants, injectors, and outcome assessors will be blinded to the group assignment.

Patients who are elected for minor laparoscopic surgeries (diagnostic laparoscopy, cystectomy, ‎salpingectomy, oophorectomy, and tubectomy) would be evaluated for the study eligibility criteria. ‎Inclusion criteria are the age of 18-65 years, body mass index <30 kg/m2, and American Society ‎of Anesthesiologists grade I or II. Exclusion criteria are allergy to analgesics, ‎anticoagulant consumption during the last four weeks, daily intake of opioids or anti-anxiety ‎medications, fever, or bacterial infection within the last two weeks

Participants will be allocated to the three study groups, 38 patients each. The study includes two intervention groups (dexamethasone and ketorolac) and one control group (placebo). The ‎first group will receive 30 mg intravenous ketorolac (15 mg/ml, 2 ml). The second group will receive 8 ‎mg intravenous dexamethasone (4 mg/ml, 2 ml). The third group (placebo group) will receive 2 ml ‎intravenous normal saline.

Postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting

A simple randomization approach will be implemented in this study. Randomization will be performed using a computer-generated list. For this purpose, 114 sealed ‎envelopes will be numbered 1-114 according to the randomization list. Group allocation ‎will be kept separate until the study is completed. The randomization ratio would be 1: 1, with 38 ‎envelopes allocated to each group.

A nurse that is not ‎involved in the study opened a sealed envelope in a closed medicine room 30–60 min before the ‎operation. According to the envelope code, the analgesics or placebo were drawn into a 2-ml syringe and intravenously ‎injected into the participants. All solutions are transparent and visually similar.‎Therefore, both injectors and recipients were kept blinded to the group allocation.‎ Outcome assessors will be kept blinded from the patients' allocation, as well.

All the potential data sets are sharable after anonymizing.

Starting 6 months after publication.

Only available for people working in academic institutions.

All types of analyses of the data sets are allowed.

Doctor Zahra Asgari Tel: 0098 21 9133588917 Email: asgariza@sina.tums.ac.ir

The applicant submits his / her application via email to the responsible researcher and after identification, the requested information will be sent within one month.