Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Post Tonsillectomy Emergence Agitation
In brief
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.
Key facts
- Study ID
- NCT07375342
- Run by
- Benha University
- People needed
- 120
- Starts
- 2025-12-10
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- American Society of Anesthesiologists (ASA) physical status I or II.
- Parent/legal guardian provides written informed consent
You may not qualify if…
- • Known allergy or contraindication to melatonin.
- Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD).
- Children receiving any sedative or psychoactive medication within 48 hours of surgery.
- Emergency surgery or any procedure other than tonsillectomy/adenoidectomy.
- Children with known sleep disorders or those taking melatonin supplements.
- Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively.
- Hepatic or renal dysfunction (ALT/AST >2×ULN, Cr >1.5 mg/dL)
Where it is running
- Benha University Hospital — Banhā, Egypt (enrolling)
Full record on ClinicalTrials.gov
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