Oral melatonin versus nebulized dexmedetomidine to reduce emergence agitation after adenotonsillectomy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 3–7 with ASA physical status I–II who are scheduled for elective adenotonsillectomy receive a preoperative dose of either oral melatonin, nebulized dexmedetomidine, or normal saline. Emergence agitation and postoperative pain are monitored in the immediate recovery period using standard clinical scales. Patients with developmental delay, central nervous system disorders, recent use of anticonvulsants or sedative medications, or known allergies to the study drugs are excluded. The trial compares the frequency and severity of emergence agitation between the intervention groups to determine which premedication strategy provides better wake-up behavior.

Why it matters

Who can join: the full rules

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

Where it's running

• Tanta University
  Tanta, El-Gharbia, Egypt Recruiting

Study contacts

• Study coordinator: Amany A Eid, MSc
• Email: amany.kamel@med.tanta.edu.eg
• Phone: 00201012301802

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy

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• Intranasal dexmedetomidine versus oral midazolam for premedication in children having elective inguinal or urological surgery

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• Repeated verbal orientation reminders to reduce emergence agitation after general anesthesia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.