Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorBenha University
About this trial
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
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I or II.
Parent/legal guardian provides written informed consent
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin
DrugParticipants 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. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
Placebo
DrugParticipants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Group M (Melatonin Group)Active comparator 1 intervention
Group B: Group P (Placebo Group)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
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
Time frame
5, 10, 15, and 30 minutes after arrival in the PACU.Secondary outcomes
1
Time to Discharge
Measured as the time from PACU arrival to achieving a modified Aldrete score (a 10-point system used in the post-anesthesia care unit (PACU) to assess a patient's recovery and determine if they are ready for discharge. It evaluates five categories: Activity, Respiration, Circulation, Consciousness, and Oxygen saturation. Each category is scored from 0 to 2, and a total score of 9 or 10 generally indicates that the patient can be safely discharged from the PACU). ≥9 (min),
Time frame
10-30 min from arriving to PACU2
Postoperative Pain
Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at the same time points as the PAED scale.
Time frame
first 2 hours postoperative3
Rescue Analgesia
Total dose of rescue analgesia (e.g., intravenous morphine or fentanyl measured according to the child weight in kg ) required in the PACU.
Time frame
24 hours after surgery4
Adverse Events
Incidence of PONV, respiratory depression (defined as {SpO}\_2 \< 90% requiring intervention), bradycardia (\<60 bpm), intraoperative hemodynamic instability excessive sedation (Ramsay Sedation Scale \> 3) and other adverse events.
Time frame
first 24-hour post operativeSponsors and contacts
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Source ClinicalTrials.gov