Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal saline, Oral melatonin syrup, Nebulized dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children. Basic parameters: 3 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
Overview
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Emergence agitation [Time frame: 30 minutes after recovery]
Secondary outcome measures (4)
- Perioperative anxiety [Time frame: During transferring to operating room (Up to 30 minutes).]
- Mask tolerance [Time frame: Intraoperatively]
- Degree of pain [Time frame: Before home discharge (Up to 6 hours)]
- Total postoperative analgesics consumption [Time frame: Before home discharge (Up to 6 hours)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07345715 · 36265MD430/6/25