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IRCT20230516058207N1 IRCT 2023-06-13 Research Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz Evaluation the effects of different doses of Melatonin on pain control after surgery and their effects on the need for opioid and non-opioid analgesics in patients who are candidates for spinal anesthesia Evaluation the effects of different doses of Melatonin on pain control after surgery and their effects on the need for opioid and non-opioid analgesics in patients who are candidates for spinal anesthesia: a double-blind clinical trial 2023-06-26 anticipated 152 Complete https://irct.ir/trial/70181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process is done with Random Allocation Software and the block method is used, and the block size is 8 people and the number of blocks is 19 items. The randomization unit is individual. In order to hide the treatment allocation, the list of treatments are placed in sealed and numbered envelopes (to preserve the order of the sequence), Blinding description: Randomization will be done based on the method of random block permutations of eight. Before starting the sampling, the drugs are coded at the time of manufacture in the Faculty of Pharmacy. And the drugs are given to volunteer patients by a nurse who has no role in data collection and data analysis. The participant and the researcher who collects the data and evaluates the patients do not know the type of patient intervention. 3 postoperative pain. Intervention 1: Intervention group: Group A received Melatonin sublingual tablet 3 mg (Norm Life manufactured by Amin Pharmaceutical Company, Iran)+ 1 sublingual placebo tablet (made in the growth center of Ahvaz Faculty of Pharmacy). Intervention 2: Intervention group: Group B received Melatonin sublingual tablet 10 mg (Norm Life manufactured by Amin Pharmaceutical Company, Iran) + 1 sublingual placebo tablet (made in the growth center of Ahvaz Faculty of Pharmacy). Intervention 3: Intervention group: Group C received 2 sublingual tablets of melatonin 10 mg (20 mg in total) (Norm Life manufactured by Amin Pharmaceutical Company, Iran). Intervention 4: Control group: Group D received 2 placebo sublingual tablets (manufactured in the growth center of Ahvaz Faculty of Pharmacy). 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 Iman Abdolkhani
Jundishapur University of Medical Sciences Ahvaz Faculty of Pharmacy., Golestan Blvd.,Ahvaz City.
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3338 5098 abdolkhani.I@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mandana Izadpanah
Jundishapur University of Medical Sciences Ahvaz Faculty of Pharmacy., Golestan Blvd.,Ahvaz City.
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8381 izadpanah-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Be over 18 years old Candidate patients for spinal anesthesia Completing the informed consent form 18 years no limit Both Patients with liver failure (liver enzymes more than triple the normal limit) Patients with renal failure (GFR<60) pregnancy Patients with brain tumors. Patients who have a history of neurological and psychological diseases People who take warfarin Drug abuse History of sensitivity to melatonin The patient's unwillingness to participate in the study G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Group A received Melatonin sublingual tablet 3 mg (Norm Life manufactured by Amin Pharmaceutical Company, Iran)+ 1 sublingual placebo tablet (made in the growth center of Ahvaz Faculty of Pharmacy) Intervention group: Group B received Melatonin sublingual tablet 10 mg (Norm Life manufactured by Amin Pharmaceutical Company, Iran) + 1 sublingual placebo tablet (made in the growth center of Ahvaz Faculty of Pharmacy) Intervention group: Group C received 2 sublingual tablets of melatonin 10 mg (20 mg in total) (Norm Life manufactured by Amin Pharmaceutical Company, Iran) Control group: Group D received 2 placebo sublingual tablets (manufactured in the growth center of Ahvaz Faculty of Pharmacy) Intensity of pain. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Dosage of opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used. The dosage of non-opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used. Side effects include drowsiness, fatigue, confusion, headache, irritability, nausea, vomiting and itching. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Ask the patient. Research Vice-Chancellor of Jundishapur University of Medical Sciences, Ahvaz Approved 2023-05-06 Ethics committee of Jundishapur University of Medical Sciences, Ahvaz No.83, West Sepid Ave.,Kian abd.,Ahvaz City Ahvaz Khouzestan Iran (Islamic Republic of)