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

Tanta University

Status: Enrolling

Conditions: Adenotonsillectomy; Emergence Agitation; Nebulized Dexmedetomidine; Children; Oral Melatonin

Treatments: Drug: Normal saline; Drug: Nebulized dexmedetomidine; Drug: Oral melatonin syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT07345715

36265MD430/6/25

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

96 participants in 3 patient groups

Group C (Control Group)

Active Comparator group

Description:

Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.

Treatment:

Drug: Normal saline

Melatonin Group

Experimental group

Description:

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

Treatment:

Drug: Oral melatonin syrup

Dexmedetomidine Group

Experimental group

Description:

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.

Treatment:

Drug: Nebulized dexmedetomidine