Actively Recruiting
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
Led by Al-Azhar University · Updated on 2026-01-06
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Al-Azhar University
Lead Sponsor
A
Al-Ayen Iraqi University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Preoperative anxiety is a frequent problem in children undergoing anesthesia, often caused by uncertainty and lack of control during medical procedures. This trial evaluates oral melatonin as a premedication to reduce anxiety in children aged 4 to 10 years having elective surgery. Researchers compare two doses of melatonin to a placebo to study their effects on preoperative anxiety and sedation. Participants will be randomly assigned to one of three groups: one receiving 0.2 mg/kg oral melatonin, another receiving 0.4 mg/kg oral melatonin, and a third receiving a placebo. All treatments are given in the morning of surgery, 90 minutes before anesthesia, with a maximum melatonin dose of 10 mg. The study is single-blind and aims to observe differences in anxiety and sedation levels. Children will be monitored for preoperative anxiety and sedation within 24 hours of treatment. Researchers will assess anxiety intensity and sedation effects to understand melatonin's impact compared to placebo. The trial includes evaluations before surgery and continuous observation to ensure safety and accurate measurement of outcomes.
CONDITIONS
Brief Title
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of either sex
- Age from 4 to 14 years
- American Society of Anesthesiologist physical status I or II
- Undergoing elective surgeries
You will not qualify if you...
- American Society of Anesthesiologist status more than III
- Drug allergy
- Gastrointestinal disorders
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive oral melatonin or placebo as premedication on the morning of surgery, 90 minutes before anesthesia.
1 visit on surgery day (in-person)
Duration - 24 hours
Participants are observed for preoperative anxiety and sedation for 24 hours after treatment.
1 follow-up visit or assessment within 24 hours post-treatment
Trial Site Locations
Total: 2 locations
1
Facualty of Pharmacy, Al Azhar University
Cairo, Cairo Governorate, Egypt, 11765
Actively Recruiting
2
Al-Ayen Univerisity
Madīnat Bābil, Babel, Iraq, 51015
Actively Recruiting
Research Team
N
Neveen Kohaf, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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