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

NCT07345715 | Recruiting

• 1 other identifier: 36265MD430/6/25
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Emergence agitation

  Emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of ≥10 has 64% sensitivity and 86% specificity for the diagnosis of Emergence Agitation (ED). A score of \>12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED.

  30 minutes after recovery

Secondary Outcomes (4)

• Perioperative anxiety

  During transferring to operating room (Up to 30 minutes).

• Mask tolerance

  Intraoperatively

• Degree of pain

  Before home discharge (Up to 6 hours)

• Total postoperative analgesics consumption

  Before home discharge (Up to 6 hours)

Study Arms (3)

Group C (Control Group)

ACTIVE COMPARATOR

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

Drug: Normal saline

Melatonin Group

EXPERIMENTAL

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

Drug: Oral melatonin syrup

Dexmedetomidine Group

EXPERIMENTAL

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.

Drug: Nebulized dexmedetomidine

Interventions

Nebulized dexmedetomidine DRUG

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.

Dexmedetomidine Group

Normal saline DRUG

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

Group C (Control Group)

Oral melatonin syrup DRUG

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

Melatonin Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Amany A Eid, MSc

CONTACT

00201012301802; amany.kamel@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)