Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Benha University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Group M (Melatonin Group)
Intervention: Melatonin (Drug)
Group P (Placebo Group)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA
Secondary Outcomes
- Time to Discharge(10-30 min from arriving to PACU)
- Postoperative Pain(first 2 hours postoperative)
- Rescue Analgesia(24 hours after surgery)
- Adverse Events(first 24-hour post operative)
- Parent/caregiver satisfaction(first 24-hour post operative)
Investigators
Taghreed Elshahat Sakr
lecturer of anesthesia and icu
Benha University