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IRCT20190511043550N6 IRCT 2026-06-27 Shiraz University of Medical Sciences Effect of Melatonin Administration Before Eyelid Surgery on Reducing Postoperative Pain: A Clinical Study in Shiraz Hospitals Investigating the effect of melatonin administration before blepharoplasty surgery on pain reduction after surgery In the hospital centers of Shiraz University of Medical Sciences in ۱۴۰۴-۱۴۰۵: A randomized controlled clinical trial 2026-07-23 anticipated 81 Recruiting https://irct.ir/trial/90884 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a randomization table with block sizes of 3 and 6 was considered for 81 patients (27 patients per group). A total of 81 eligible patients were randomly assigned to the three study groups in a 1:1:1 ratio, with 27 participants in each group, Blinding description: This study is triple-blind, meaning that the patient, the researcher, and the statistical analyst are unaware of the intervention type. Patient coordination and data collection are carried out in collaboration with the surgeon to ensure prevention of bias in the data and to maintain confidentiality. 2 Blepharoplasty. Intervention 1: Intervention groupA: Patients in this group receive one 5 mg melatonin tablet the night before surgery and placebo (starch with similar shape and color) on the morning of surgery. Intervention 2: Intervention group B: Patients in this group receive placebo the night before surgery and one 5 mg melatonin tablet one hour before the operation. Intervention 3: Control group C: Patients in this group receive placebo both the night before surgery and one hour before the operation (double placebo). 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 It is against our policy.
public Vahide Emamifar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3630 4312 v.emamifar@yahoo.com Shiraz University of Medical Sciences scientific Ashkan Panah
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 panah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with ASA grade I or II (American Society of Anesthesiology classification) Patients between 20 and 60 years old Obtaining Informed Consent from the Patient 20 years 60 years Both Surgery duration exceeding 1.5 hours Wider surgical incision Sensitivity to the studied drugs H02.83 Dermatochalasis of eyelid Treatment - Drugs Treatment - Drugs Placebo Intervention groupA: Patients in this group receive one 5 mg melatonin tablet the night before surgery and placebo (starch with similar shape and color) on the morning of surgery. Intervention group B: Patients in this group receive placebo the night before surgery and one 5 mg melatonin tablet one hour before the operation. Control group C: Patients in this group receive placebo both the night before surgery and one hour before the operation (double placebo). Pain. Timepoint: at 2, 6, 12 and 24 hours after the operation. Method of measurement: Visual Analogue Scale. Shiraz University of Medical Sciences Approved 2026-05-03 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)