Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
NCT ID: NCT07345715
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2025-07-01
2027-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Melatonin Group
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Oral melatonin syrup
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
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.
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.
Interventions
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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.
Oral melatonin syrup
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
7 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Amany Abd Elsamd Kamel Eid
Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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36265MD430/6/25
Identifier Type: -
Identifier Source: org_study_id
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