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

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

Recruiting
3-7 years
All
Phase N/A

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Overview

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

Description

Adenotonsillectomy is one of the most commonly performed surgical procedures in children with high incidence of emergence agitation about 80% and high degree of post operative pain.

Oral midazolam, a short-acting benzodiazepine, is commonly used as a standard premedication in children due to its well-established anxiolytic, sedative, and amnestic effects. It works by enhancing GABAergic neurotransmission in the central nervous system, helping reduce anxiety and facilitating a smoother anesthetic induction and emergence.

Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action.

Eligibility

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

Study details
    Oral Melatonin
    Nebulized Dexmedetomidine
    Emergence Agitation
    Children
    Adenotonsillectomy

NCT07345715

Tanta University

1 February 2026

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