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IRCT20221205056716N1 IRCT 2023-03-11 Qazvin University of Medical Sciences ٍٍEffect of Caffeine injection on pain after Cholecystectomy The effect of intravenous injection of Caffeine on reducing pain after laparoscopic Cholecystectomy 2023-05-05 anticipated 60 Complete https://irct.ir/trial/67219 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks, Blinding description: The anesthesiologist receives the drugs which are coded in closed envelopes and injects them into the patients. Coding is done by one of the colleagues of the project and the doctor, anesthesiologist, analyzer, and patient are blinded. 3 Patients undergoing laparoscopic cholecystectomy. Intervention 1: Intervention group: After entering the operating room, the patients undergo laparoscopic cholecystectomy under general anesthesia. After entering recovery, the experimental group was given caffeine injection drug by the anesthesiologist as an analgesic with a dose of 1 mg on a medicinal plant with medicinal characteristics: caffeine citrate 10 mg (3 ml) from Kimia drug company - maximum 60 mg per dose. It is injected intravenously to reduce pain. The pain level of the patient is recorded 10, 30, and 60 minutes after the intervention by a trained doctor or nurse. After the necessary coordination with the surgeon and the recovery nurses, for pain intensity between 4 and 6, 0.25 mg/kg of Pethidine, and for intensity Pain between 7 and 10, 0.5 mg/kg of Pethidine is injected and recorded in the patient's file. Intervention 2: Control group: After entering the operating room, the patients undergo laparoscopic cholecystectomy under general anesthesia. After entering recovery, 3cc of normal saline is injected intravenously into the control group. The pain level of the patient is recorded 10, 30, and 60 minutes after the intervention by a trained doctor or nurse. After the necessary coordination with the surgeon and the recovery nurses, for pain intensity between 4 and 6, 0.25 mg/kg of pethidine, and for intensity Pain between 7 and 10, 0.5 mg/kg of pethidine is injected and recorded in the patient's file. Yes - There is a plan to make this available What will be shared: All data can be shared after individuals are de-identified When: Access starts 6 months after results are published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Any kind of analysis on the delivered data is allowed Where to obtain: Refer to Dr. Shabnam's email "tikokhan@yahoo.com" How to obtain: After publishing the article, the applicant can send a clear request to the author to access the data by sending an email. So, after reviewing the request within 2 weeks, access to data and information is allowed. Comments:
public Mohammadreza Shabnam
Bahonar street
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 tikokhan@yahoo.com Qazvin University of Medical Sciences scientific Mohammadreza Shabnam
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 tikokhan@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age range 15-60 years Candidate for Cholecystectomy surgery Informed consent 15 years 60 years Both Pregnancy and breastfeeding and abortion less than 3 months Hyperthyroidism History of smoking, alcohol and drugs Chronic mental and physical illness (Schizophrenia, Diabetes, etc.) Vision and hearing problems and other disabilities Corticosteroids, Antihistamines, and painkillers consumption for a long time (at least 2 months) Allergy to Caffeine and Pethidine History of surgery K80 Cholelithiasis Treatment - Drugs Placebo Intervention group: After entering the operating room, the patients undergo laparoscopic cholecystectomy under general anesthesia. After entering recovery, the experimental group was given caffeine injection drug by the anesthesiologist as an analgesic with a dose of 1 mg on a medicinal plant with medicinal characteristics: caffeine citrate 10 mg (3 ml) from Kimia drug company - maximum 60 mg per dose. It is injected intravenously to reduce pain. The pain level of the patient is recorded 10, 30, and 60 minutes after the intervention by a trained doctor or nurse. After the necessary coordination with the surgeon and the recovery nurses, for pain intensity between 4 and 6, 0.25 mg/kg of Pethidine, and for intensity Pain between 7 and 10, 0.5 mg/kg of Pethidine is injected and recorded in the patient's file. Control group: After entering the operating room, the patients undergo laparoscopic cholecystectomy under general anesthesia. After entering recovery, 3cc of normal saline is injected intravenously into the control group. The pain level of the patient is recorded 10, 30, and 60 minutes after the intervention by a trained doctor or nurse. After the necessary coordination with the surgeon and the recovery nurses, for pain intensity between 4 and 6, 0.25 mg/kg of pethidine, and for intensity Pain between 7 and 10, 0.5 mg/kg of pethidine is injected and recorded in the patient's file Pain level after laparoscopic cholecystectomy. Timepoint: 10, 30 and 60 minutes after the operation. Method of measurement: Ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable). The amount of Pethidine consumed. Timepoint: Until exiting recovery. Method of measurement: Record the amount of injected doses in the checklist. Qazvin University of Medical Sciences Approved 2023-03-01 Ethics Committee of Qazvin University of Medical Sciences Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)