Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Emergence agitation
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Normal saline (Drug)
Melatonin Group
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Intervention: Oral melatonin syrup (Drug)
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.
Intervention: Nebulized dexmedetomidine (Drug)
Outcomes
Primary Outcomes
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
- Perioperative anxiety(During transferring to operating room (Up to 30 minutes).)
- Mask tolerance(Intraoperatively)
- Degree of pain(Before home discharge (Up to 6 hours))
- Total postoperative analgesics consumption(Before home discharge (Up to 6 hours))
Investigators
Amany Abd Elsamd Kamel Eid
Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.
Tanta University