NCT07375342 · RECRUITING
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
This trial is testing whether a dose of melatonin given before surgery can reduce the agitation and confusion children sometimes experience waking up from anesthesia after a tonsillectomy. Researchers will compare melatonin to a placebo to see if it makes recovery calmer. This is a Phase NA trial, meaning it is a straightforward interventional study focused on a specific clinical question rather than a staged drug development program.
Eligibility criteria
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-17