NCT07375342 Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
| NCT ID | NCT07375342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benha University |
| Condition | Post Tonsillectomy Emergence Agitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-12-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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)
Frequently Asked Questions
Who can join the NCT07375342 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 10 Years, studying Post Tonsillectomy Emergence Agitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07375342 currently recruiting?
Yes, NCT07375342 is actively recruiting participants. Visit ClinicalTrials.gov or contact Benha University to inquire about joining.
Where is the NCT07375342 trial being conducted?
This trial is being conducted at Banhā, Egypt.
Who is sponsoring the NCT07375342 clinical trial?
NCT07375342 is sponsored by Benha University. The trial plans to enroll 120 participants.