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Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 10
Healthy Volunteers: f
View:

• American Society of Anesthesiologists (ASA) physical status I or II.

• Parent/legal guardian provides written informed consent

Locations
Other Locations
Egypt
Benha University Hospital
RECRUITING
Banhā
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 120
Treatments
Active_comparator: Group M (Melatonin Group)
Placebo_comparator: Group P (Placebo Group)
Related Therapeutic Areas
Sponsors
Leads: Benha University

This content was sourced from clinicaltrials.gov