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IRCT20220507054763N1 IRCT 2022-07-13 Vice-Chancellery for Research Hormozgan University of Medical Sciences The effect of melatonin on post-appendectomy pain The effect of melatonin versus placebo on post-appendectomy pain 2018-11-22 anticipated 64 Complete https://irct.ir/trial/64717 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. Allocation concealment will be done using unclear envelopes, Blinding description: Patients in the control group will receive placebo in the same color and form of melatonin. Given that placebo is prepared by the pharmaceutical company which is uninvolved in the study, the patients, the care givers, and the anesthesiologist will be unaware of the received intervention. Also, post-appendectomy pain will be assessed by the patients (blinded to the type of intervention) and sedation will be assessed by the anesthesiologist (the assessor who is blinded to the patient grouping). 3 Post-appendectomy pain. Intervention 1: Intervention group: One hour before surgery, two 3 mg melatonin tablets (a total of 6 mg) manufactured by Vitans Nature, USA. Intervention 2: Control group: One hour before surgery, two 3 mg placebo tablets (a total of 6 mg) manufactured by Vitans Nature, USA. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Alireza Abdollahzadeh Baghaei
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
Bandar Abbas Iran (Islamic Republic of) 9791991551 +98 76 3334 5009 bagha_ar@yahoo.com Bandare-abbas University of Medical Sciences scientific Alireza Abdollahzadeh Baghaei
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
Bandar Abbas Iran (Islamic Republic of) 979199155 +98 76 3334 5009 bagha_ar@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Age of 18-80 years ASA class I & II Candidacy for appendectomy under general anesthesia 18 years 80 years Both Addiction Allergy to melatonin Neurological or psychiatric disease History of taking analgesics for other reasons G89.18 Other acute postprocedural pain Prevention Placebo Intervention group: One hour before surgery, two 3 mg melatonin tablets (a total of 6 mg) manufactured by Vitans Nature, USA Control group: One hour before surgery, two 3 mg placebo tablets (a total of 6 mg) manufactured by Vitans Nature, USA Post-appendectomy pain. Timepoint: At 2, 12, and 24 hours after surgery. Method of measurement: Visual analogue scale. The amount of analgesics required. Timepoint: Up to 24 hours after surgery. Method of measurement: gr pethidine. Sedation. Timepoint: At 2, 12, and 24 hours after surgery. Method of measurement: Ramsay Sedation Scale (RSS). Side effects, including hypotension, bradycardia, and respiratory depression. Timepoint: Up to 24 hours after surgery. Method of measurement: Measurement of blood pressure (systolic blood pressure <90 mmHg), heart beat (<60), and respiratory rate (<12). Vice-Chancellery for Research Hormozgan University of Medical Sciences Approved 2018-10-14 Ethics Committee of Hormozgan University of Medical Sciences Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine Bandar Abbas Hormozgan Iran (Islamic Republic of)