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ENROLLING BY INVITATION
NCT07375342
NA

Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

Sponsor: Benha University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

4 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-10

Completion Date

2026-06-01

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

Melatonin

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. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,

DRUG

Placebo

Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,

Locations (1)

Benha University Hospital

Banhā, Egypt