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Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

RecruitingNAAges 4 Years - 10 YearsAllBenha University
NCT07375342 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I or II. * Parent/legal guardian provides written informed consent Exclusion Criteria: * โ€ข 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 \>2ร—ULN, Cr \>1.5 mg/dL)
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What it tests

  • Melatonin
  • Placebo
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Where

1 site
Benha University Hospital
Banhฤ, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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