Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
Tanta University
96 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
Eligibility
Inclusion Criteria4
- Children aged between 3 and 7 years.
- Both sexes.
- Classified as American Society of Anesthesiologists (ASA) physical status I or II according to the American Society of Anesthesiologists.
- Scheduled for elective adenotonsillectomy under general anesthesia.
Exclusion Criteria7
- Parental refusal to participate in the study.
- Known allergy or hypersensitivity to dexmedetomidine, melatonin or midazolam.
- Presence of developmental delay.
- Central nervous system disorders.
- Intellectual disability (formerly termed mental retardation).
- Neurological or psychiatric conditions associated with anxiety or agitation (e.g., cerebral palsy, epilepsy, separation anxiety disorder, attention-deficit/hyperactivity disorder).
- Current or recent treatment with anticonvulsants or sedative medications
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Interventions
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Participants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07345715