Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Placebo.
- Who it may be relevant to
- Registry conditions: Post Tonsillectomy Emergence Agitation. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial
Overview
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.
Interventions
- Drug Melatonin
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. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration, - Drug Placebo
Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
Primary outcome measures
- Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale [Time frame: 5, 10, 15, and 30 minutes after arrival in the PACU.]
Secondary outcome measures (5)
- Time to Discharge [Time frame: 10-30 min from arriving to PACU]
- Postoperative Pain [Time frame: first 2 hours postoperative]
- Rescue Analgesia [Time frame: 24 hours after surgery]
- Adverse Events [Time frame: first 24-hour post operative]
- Parent/caregiver satisfaction [Time frame: first 24-hour post operative]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Benha University Hospital — Banhā
Identifiers
NCT: NCT07375342 · RC.2.11.2025