Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

Benha University

Status

Invitation-only

Conditions

Post Tonsillectomy Emergence Agitation

Treatments

Drug: Placebo

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT07375342

RC.2.11.2025

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists (ASA) physical status I or II.
Parent/legal guardian provides written informed consent

Exclusion criteria

• 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)