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IRCT20190811044506N1 IRCT 2019-08-31 Mashhad University of Medical Sciences The effect of melatonin on the severity of postoperative pain Effect of preoperative sub-lingual melatonin on postoperative pain of patients undergoing colorectal surgery 2019-09-23 anticipated 60 Complete https://irct.ir/trial/41781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with inclusion criteria were divided into control and intervention groups using random numbers table by simple randomization method, Blinding description: The subjects were randomly divided into intervention and control groups after receiving written and informed consent so that they were unaware of their assigned group. The original drug and placebo, which are similar in shape, color and size, are delivered to the patient by the unconscious clinical caregiver. N/A Condition 1: postoperative pain. Condition 2: abdominal pain. Intervention 1: Intervention group: 6 mg melatonin sublingual one hour before surgery. Intervention 2: Control group: 6 mg placebo sublingual one hour before surgery. 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 The publication of individual patient data requires the approval of the University Ethics Committee.
public Maryam Shakiba
Daneshghah
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3601 5168 shakibam961@mums.ac.ir Mashhad University of Medical Sciences scientific Maryam Shakiba
Daneshghah
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3601 5168 shakibam961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient is a candidate for colorectal surgery. ASA Classification of 1 and 2 Give informed, voluntary and written consent Have not used any narcotic drugs before surgery. 18 years 65 years Both a history of alcohol or drug abuse a history of Seizure a history of diabetes T81 R10 Complications of procedures, not elsewhere classified Abdominal and pelvic pain Treatment - Drugs Placebo Intervention group: 6 mg melatonin sublingual one hour before surgery Control group: 6 mg placebo sublingual one hour before surgery Postoperative pain severity. Timepoint: 0, 2, 6, 12 and 24 hours after surgery. Method of measurement: Verbal rating scale. Sedation. Timepoint: 6, 12 and 24 hours after surgery. Method of measurement: Ramsay sedation score. Mashhad University of Medical Sciences Approved 2019-04-30 Ethics committee of Mashhad University of Medical Sciences Vakilabad Blvd, School of Medicine Mashhad Razavi Khorasan Iran (Islamic Republic of)