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
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 2026: A randomized controlled clinical trial
Design
This is a triple-blind, parallel-design randomized clinical trial. A total of 81 candidates for blepharoplasty will be included. Eligible patients will be equally allocated to three groups (A, B, and C) using block randomization.
Settings and conduct
Patients who are candidates for blepharoplasty surgery and present to Shahid Dastghieb Hospital in Shiraz during the study period will be enrolled if they meet the eligibility criteria and will be randomly allocated to intervention and control groups using block randomization. This study will be conducted as a triple-blind trial, meaning that the patients, the researcher, the outcome assessor, and the statistical analyst will be unaware of the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with ASA class I or II (American Society of Anesthesiologists classification), patients aged between 18 and 65 years.
Exclusion criteria:
Surgery duration exceeding 1.5 hours, enlargement of the surgical incision area, and sensitivity (allergy) to the studied drugs.
Intervention groups
Intervention group A: 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).
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043550N6
Registration date:2026-06-27, 1405/04/06
Registration timing:prospective
Last update:2026-06-27, 1405/04/06
Update count:0
Registration date
2026-06-27, 1405/04/06
Registrant information
Name
Ashkan Panah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
panah@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Melatonin Administration Before Eyelid Surgery on Reducing Postoperative Pain: A Clinical Study in Shiraz Hospitals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Surgery duration exceeding 1.5 hours
Wider surgical incision
Sensitivity to the studied drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2026-05-03, 1405/02/13
Ethics committee reference number
IR.SUMS.MED.REC.1405.040
Health conditions studied
1
Description of health condition studied
Blepharoplasty
ICD-10 code
H02.83
ICD-10 code description
Dermatochalasis of eyelid
Primary outcomes
1
Description
Pain
Timepoint
at 2, 6, 12 and 24 hours after the operation.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Intervention group B: Patients in this group receive placebo the night before surgery and one 5 mg melatonin tablet one hour before the operation.
Category
Treatment - Drugs
3
Description
Control group C: Patients in this group receive placebo both the night before surgery and one hour before the operation (double placebo).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Vahide Emamifar
Street address
Hafez Street, Hafeziyeh Intersection.
City
Shiraz
Province
Fars
Postal code
۷۱۴۵۶۸۳۷۶۹
Phone
+98 71 3228 4280
Email
dastgheib@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand stree
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
mohammadi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahide Emamifar
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3630 4312
Email
v.emamifar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ashkan Panah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street