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IRCT20140611018063N6 IRCT 2019-09-03 Birjand University of Medical Sciences Diclofenac vs. Pethidine in cholecystectomy pain Comparison of the Effect of Diclofenac and Pethidine on the severity of the Postoperative Pain of Laparoscopic Cholecystectomy in Opiate-Dependent and Non-Dependent Patients. 2015-11-01 anticipated 120 Complete https://irct.ir/trial/39512 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 packed packs including 30 packs with a paper with letter “A” written on it and 30 packs with a paper with letter “B” written on it will be generated. Letter “A” represents the group receiving pethidine and letter “B” represents the group receiving diclofenac. Using block randomization and packed envelopes, the opioid dependent group will be divided randomly and equally into two groups: one will receive diclofenac and the other will receive pethidine. By block randomization and packed envelopes, the non-opioid dependent group will be divided randomly and equally into two groups: one group will receive diclofenac and the other group will receive pethidine. , Blinding description: A nurse who does not know the prescribed drug uses the Verbal Rating Scale to evaluates the severity of pain in the patients. 3 Condition 1: pain. Condition 2: Cholelithiasis. Condition 3: Acute cholecystitis. Intervention 1: Intervention group: One subset of opioid-dependent patients will be given 100 mg Diclofenac suppository through the rectal starting from 1 hour after the recovery and repeated every 6 hours until 24 hours;. Intervention 2: Intervention group: One subset of opioid-independent patients will be given 100 mg Diclofenac suppository through the rectal starting from 1 hour after the recovery and repeated every 6 hours until 24 hours;. Intervention 3: Intervention group: one subset of opioid-dependent patients will be given 25 mg pethidine injection intravenously starting from 1 hour after the recovery and repeated every 6 hours until 24 hours;. Intervention 4: Intervention group: one subset of opioid-independent patients will be given 25 mg pethidine injection intravenously starting from 1 hour after the recovery and repeated every 6 hours until 24 hours. Yes - There is a plan to make this available What will be shared: The entire statistical data from this study can be shared as needed based on the ethics committee's criteria. When: The results of this study, after publishing the results as a paper, will be published and shared. To whom: The data from this study will be available to all researchers. Conditions: All academic researchers, in the form of research projects approved by the Ethics Committee, are allowed to access the data and perform the necessary analyzes on the documentation of this research. Where to obtain: Applicants for obtaining documentation of this study can request information by email with the corresponding author. How to obtain: Researchers should send the research proposal code and ethics committee registrant code with the applicant email. Comments:
public Ali Rajabpour-Sanati
NO. 37, 13th Modarres
Birjand Iran (Islamic Republic of) 9717911766 +98 56 3234 1067 ali.poursanati@gmail.com Birjand University of Medical Sciences scientific Dr. Mohammad Yarani
Moallem Blvd.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 mohammadyarani@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) patients with detected gallstones requiring surgery patients with biliary sludge requiring surgery no limit no limit Both history of laparoscopic cholecystectomy severe obstructive pulmonary disease congestive heart failure (EF <20%) acute cholecystitis gangrenous empyema gallbladder intestinal fistula in the biliary tract obesity pregnancy ventriculoperitoneal shunt previous abdominal surgery appearance of serious drug side effects cirrhosis R52.0 K80 K81.0 Acute pain Cholelithiasis Acute cholecystitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: One subset of opioid-dependent patients will be given 100 mg Diclofenac suppository through the rectal starting from 1 hour after the recovery and repeated every 6 hours until 24 hours; Intervention group: One subset of opioid-independent patients will be given 100 mg Diclofenac suppository through the rectal starting from 1 hour after the recovery and repeated every 6 hours until 24 hours; Intervention group: one subset of opioid-dependent patients will be given 25 mg pethidine injection intravenously starting from 1 hour after the recovery and repeated every 6 hours until 24 hours; Intervention group: one subset of opioid-independent patients will be given 25 mg pethidine injection intravenously starting from 1 hour after the recovery and repeated every 6 hours until 24 hours. The effect of prescribed drug on the severity of pain. Timepoint: measuring severity of the pain before intervention, measuring severity of the pain 24 hours after the initiation of the anti-pain drug (pethidine or diclofenac). Method of measurement: verbal rating scale of pain. Birjand University of Medical Sciences Approved 2015-04-12 Birjand University of Medical Sciences NO. 37, 13th Modarres Street Birjand South Khorasan Iran (Islamic Republic of)