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New treatment option for Post Tonsillectomy Emergence Agitation
Official title Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
ClinicalTrials.gov ID: NCT07375342
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for post tonsillectomy emergence agitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 10
You may be able to join if
- American Society of Anesthesiologists (ASA) physical status I or II.
- Parent/legal guardian provides written informed consent
You likely can't join if
- 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.
See the full eligibility criteria
- American Society of Anesthesiologists (ASA) physical status I or II.
- Parent/legal guardian provides written informed consent
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Banhā, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 10 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banhā, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.