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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
120
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. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
Participants 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,
Benha University Hospital
Banhā, Egypt
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.
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 PACU
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 postoperative
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 surgery
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 operative
Parent/caregiver satisfaction
measured at discharge (Likert scale) used to measure attitudes, opinions, and behaviors by asking respondents to rate their level of agreement or intensity of feeling regarding a statement, it include options such as strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Time frame: first 24-hour post operative
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