Oral melatonin versus nebulized dexmedetomidine to reduce emergence agitation after adenotonsillectomy in children
Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
NA · Tanta University · NCT07345715
We will test whether giving oral melatonin or nebulized dexmedetomidine before anesthesia better prevents children aged 3–7 from becoming agitated as they wake after adenotonsillectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07345715 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 3 to 7 years, ASA I–II, scheduled for elective adenotonsillectomy whose parents consent and who do not have the listed neurological, developmental, or medication exclusions are ideal candidates.
Not a fit: Children with developmental delays, central nervous system or psychiatric conditions, current or recent anticonvulsant or sedative use, or known hypersensitivity to melatonin, dexmedetomidine, or midazolam are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the intervention could reduce the frequency and severity of emergence agitation and related postoperative discomfort in young children after adenotonsillectomy.
How similar studies have performed: Previous smaller trials have shown nebulized or intravenous dexmedetomidine can reduce emergence agitation and melatonin has shown promising effects, but direct head-to-head comparisons in this population are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (RECRUITING)
Study contacts
- Study coordinator: Amany A Eid, MSc
- Email: amany.kamel@med.tanta.edu.eg
- Phone: 00201012301802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children, Adenotonsillectomy