Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

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

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.

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)