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NCT Number: NCT07375342

Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric

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.

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Key information

Conditions

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

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Egypt

Location status: Recruiting

Location contact

Taghreed Sakr, MD degree of anesthesia

CONTACT

[email protected]

00201112723187

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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)

Treatment and study plan

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,

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,

Primary outcomes

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

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

    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

Secondary outcomes

  1. Time to Discharge

    Time frame: 10-30 min from arriving to PACU

    Measured as the time from PACU arrival to achieving a modified Aldrete score (a 10-point system used in the post-anesthesia care unit (PACU) to assess a patient's recovery and determine if they are ready for discharge. It evaluates five categories: Activity, Respiration, Circulation, Consciousness, and Oxygen saturation. Each category is scored from 0 to 2, and a total score of 9 or 10 generally indicates that the patient can be safely discharged from the PACU). ≥9 (min),

  2. Postoperative Pain

    Time frame: first 2 hours postoperative

    Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at the same time points as the PAED scale.

  3. Rescue Analgesia

    Time frame: 24 hours after surgery

    Total dose of rescue analgesia (e.g., intravenous morphine or fentanyl measured according to the child weight in kg ) required in the PACU.

  4. Adverse Events

    Time frame: first 24-hour post operative

    Incidence of PONV, respiratory depression (defined as {SpO}_2 < 90% requiring intervention), bradycardia (<60 bpm), intraoperative hemodynamic instability excessive sedation (Ramsay Sedation Scale > 3) and other adverse events.

  5. Parent/caregiver satisfaction

    Time frame: first 24-hour post operative

    measured at discharge (Likert scale) used to measure attitudes, opinions, and behaviors by asking respondents to rate their level of agreement or intensity of feeling regarding a statement, it include options such as strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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