Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children, Adenotonsillectomy

In brief

This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.

Key facts

Study ID

NCT07345715

Run by

Tanta University

People needed

96

Starts

2025-07-01

Expected to finish

2027-07-01

Last updated by the study team

2026-01-16

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tanta University — Tanta, El-Gharbia, Egypt (enrolling)

Full record on ClinicalTrials.gov

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