Melatonin to reduce emergence agitation after tonsil removal in kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effect of a single oral dose of melatonin (0.5 mg/kg up to 20 mg) given 30 minutes before anesthesia induction in pediatric patients undergoing tonsillectomy/adenoidectomy. Participants are randomized to receive either melatonin or a placebo to see if it reduces emergence agitation after anesthesia. Inclusion requires ASA I or II status and informed guardian consent; several medical and sleep-related exclusions apply. The trial is led by Benha University at Benha University Hospital with no listed collaborators.

Why it matters

Who can join: the full rules

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)

Where it's running

• Benha University Hospital
  Banhā, Egypt Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.