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NCT Number: NCT07345715

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

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

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Key information

Conditions

Oral Melatonin Adenotonsillectomy Children Confusion Delirium Emergence Agitation Emergence Delirium Mental Disorders Nebulized Dexmedetomidine Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Amany A Eid, MSc

CONTACT

[email protected]

00201012301802

Mona R Elghamry, MD

SUB_INVESTIGATOR

Nagat S Elshamaa, MD

SUB_INVESTIGATOR

Osama M Rehab, MD

SUB_INVESTIGATOR

Shaimaa F Mostafa, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Emergence agitation

    Time frame: 30 minutes after recovery

    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.

Secondary outcomes

  1. Perioperative anxiety

    Time frame: During transferring to operating room (Up to 30 minutes).

    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.

  2. Mask tolerance

    Time frame: Intraoperatively

    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.

  3. Degree of pain

    Time frame: Before home discharge (Up to 6 hours)

    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.

  4. Total postoperative analgesics consumption

    Time frame: Before home discharge (Up to 6 hours)

    Total postoperative analgesics consumption will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany A Eid, MSc

CONTACT

[email protected]

00201012301802

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 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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