NCT07345715

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

Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Oral Melatonin
• Nebulized Dexmedetomidine
• Emergence Agitation
• Children
• Adenotonsillectomy

Interventions

Type	Name	Description
DRUG	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.
DRUG	Oral melatonin syrup	Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
DRUG	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Egypt