Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric (NCT07375342) | Clinical Trial Compass
RecruitingNot Applicable
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
Egypt120 participantsStarted 2025-12-10
Plain-language summary
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.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
Timeframe: 5, 10, 15, and 30 minutes after arrival in the PACU.