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Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
ID06489327

Comparing Two Oral Melatonin Doses to Reduce Anxiety Before Surgery in Children Ages 4 to 10

Led by Al-Azhar University · Updated on 2026-01-06

120

Participants Needed

2

Research Sites

N/A

Total Duration

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 mgkg oral melatonin, another receiving 0.4 mgkg 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 melatonins 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

Research Team

N

Neveen Kohaf, Ph.D

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