Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorBenha University

About this 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.

Eligibility criteria

Qualifiers

American Society of Anesthesiologists (ASA) physical status I or II.

Parent/legal guardian provides written informed consent

Disqualifiers

• 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.

Trial design

Treatments tested in this trial

  • Melatonin
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators