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

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

Study Overview

• Status: Recruiting
• Conditions: Children; Adenotonsillectomy; Emergence Agitation; Oral Melatonin; Nebulized Dexmedetomidine
• Intervention / Treatment: Drug: Normal saline; Drug: Oral melatonin syrup; Drug: Nebulized dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amany A Eid, MSc; Phone Number: 00201012301802; Email: amany.kamel@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Osama M Rehab, MD
      • Sub-Investigator: Shaimaa F Mostafa, MD
      • Contact: Amany A Eid, MSc; Phone Number: 00201012301802; Email: amany.kamel@med.tanta.edu.eg
      • Sub-Investigator: Nagat S Elshamaa, MD
      • Sub-Investigator: Mona R Elghamry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C (Control Group); 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; Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
Experimental: Melatonin Group; 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; Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Experimental: Dexmedetomidine Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative anxiety	Perioperative anxiety which will be measured by using Parental separation anxiety scale (PSAS). PSAS scale: Excellent: Patient unafraid, cooperative, or asleep.; Good: Slight fear and or crying, quiet with reassurance.; Fair: Moderate fear and crying, not quiet with reassurance.; Poor: Crying, need for restraint. Score of 1 or 2 were classified as an acceptable separation, whereas scores of 3 or 4 were considered difficult separations from the parents.	During transferring to operating room (Up to 30 minutes).
Mask tolerance	Mask tolerance which will be measured by using mask acceptance scale (MAS). MAS score: Excellent: calm, cooperative, or asleep.; Good: Moderate fear of the mask Manageable with reassurance.; Fair: Cries, combative and needs restraining.; Poor: Crying, need for restraint. Score of 1 or 2 were classified as an acceptable mask tolerance, whereas scores of 3 or 4 were considered poor mask tolerance.	Intraoperatively
Degree of pain	Postoperative pain control will be assessed using Face, Legs, Activity, Cry, Consolability (FLACC) ) on arrival to PACU, 30 minutes, one hour, two hours after surgery and before home discharge. Each category is scored on the 0-2 scale, which results in a total score of 0-10.; 0 = Relaxed and comfortable.; 1-3 = Mild discomfort.; 4-6 = Moderate pain.; 7-10 = Severe discomfort/pain.	Before home discharge (Up to 6 hours)
Total postoperative analgesics consumption	Total postoperative analgesics consumption will be recorded.	Before home discharge (Up to 6 hours)

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: 36265MD430/6/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No