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IRCT20230828059289N1 IRCT 2023-11-04 Qazvin University of Medical Sciences Comparison of the effect of morphine and pethidine injections into the pleural space to control postoperative pain in tracheotomy surgeries Comparison of the effect of intrapleural morphine and pethidine injection to control postoperative pain in trachotomy surgeries 2023-09-11 anticipated 72 Complete https://irct.ir/trial/72327 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to three treatment groups A, B, and C using the method of random blocks (Balance block randomization), the size of each block is 6 and the total number of blocks is 12. The balanced randomization allocation method for the participants in the randomized controlled clinical trial study is in the first group (A), the second group (B) and the third group (C); The variables are measured and compared between the three groups, Blinding description: The surgical resident 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, surgical resident, and patient are blinded. 2 Pain control after thoracotomy. Intervention 1: Intervention group: Group A: Morphine injection (Darou pakhsh Iran company) with a dose of 0.1 mg/kg in 40 ml of saline in the intrapleural space. Intervention 2: Intervention group: Group B: Pethidine injection (Pharmaceutical Co. Caspian Tamin) with a dose of 1 mg/kg in 40 ml of saline in the intrapleural space. Intervention 3: Control group: Group C: injection of 40 ml of normal saline in the intrapleural space. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Safieh Salim pour abkenar
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34719-76161 +98 28 3379 0620 salimpour67@gmail.com Qazvin University of Medical Sciences scientific Safieh Salim pour abkenar
22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town
Qazvin Iran (Islamic Republic of) 34719-76161 +98 28 3379 0620 salimpour67@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Age range 25-65 Candidate for tracheotomy surgery ASA class I or II Existence of informed consent 25 years 65 years Both Alcohol and drug addiction Drug sensitivity and allergy Previous chronic pain Epilepsy G89.12 Acute post-thoracotomy pain Treatment - Drugs Treatment - Drugs Placebo Intervention group: Group A: Morphine injection (Darou pakhsh Iran company) with a dose of 0.1 mg/kg in 40 ml of saline in the intrapleural space Intervention group: Group B: Pethidine injection (Pharmaceutical Co. Caspian Tamin) with a dose of 1 mg/kg in 40 ml of saline in the intrapleural space. Control group: Group C: injection of 40 ml of normal saline in the intrapleural space Severity of pain after surgery. Timepoint: From the time of admission to the ward until the time of discharge. Method of measurement: Visual Analog Scale. Duration of hospitalization. Timepoint: From the time of admission to the ward until the time of discharge. Method of measurement: Check list. The amount of narcotic drug injection. Timepoint: From the start of the surgery to the time of discharge. Method of measurement: Check list. Qazvin University of Medical Sciences Approved 2023-08-12 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)