Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

NCT07375342 | Recruiting

• 1 other identifier: RC.2.11.2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.

Conditions

Post Tonsillectomy Emergence Agitation

Keywords

agitation; tonsillectomy; pediatric

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale

  The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA

  5, 10, 15, and 30 minutes after arrival in the PACU.

Secondary Outcomes (5)

• Time to Discharge

  10-30 min from arriving to PACU

• Postoperative Pain

  first 2 hours postoperative

• Rescue Analgesia

  24 hours after surgery

• Adverse Events

  first 24-hour post operative

• Parent/caregiver satisfaction

  first 24-hour post operative

Study Arms (2)

Group M (Melatonin Group)

ACTIVE COMPARATOR

Drug: Melatonin

Group P (Placebo Group)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,

Group P (Placebo Group)

Melatonin DRUG

Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,

Group M (Melatonin Group)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II.
• Parent/legal guardian provides written informed consent

You may not qualify if:

• Known allergy or contraindication to melatonin.
• Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD).
• Children receiving any sedative or psychoactive medication within 48 hours of surgery.
• Emergency surgery or any procedure other than tonsillectomy/adenoidectomy.
• Children with known sleep disorders or those taking melatonin supplements.
• Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively.
• Hepatic or renal dysfunction (ALT/AST \>2×ULN, Cr \>1.5 mg/dL)

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Egypt

RECRUITING

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and icu

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 29, 2026
• Study Start: December 10, 2025
• Primary Completion: May 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)