Normal saline: Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
Oral melatonin syrup: Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Nebulized dexmedetomidine: 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.
Study 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
Sex
ALL
Min age
3 Years
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Emergence agitation — 30 minutes after recovery Emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of ≥10 has 64% sensitivity and 86% specificity for the diagnosis of Emergence Agitation (ED). A score of \>12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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