Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children, Adenotonsillectomy
Conditions
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.
Interventions
DRUGNormal saline
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
DRUGOral melatonin syrup
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation | 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
| Measure | Time frame | Description |
|---|---|---|
| Perioperative anxiety | During transferring to operating room (Up to 30 minutes). | Perioperative anxiety which will be measured by using Parental separation anxiety scale (PSAS). PSAS scale: 1. Excellent: Patient unafraid, cooperative, or asleep. 2. Good: Slight fear and or crying, quiet with reassurance. 3. Fair: Moderate fear and crying, not quiet with reassurance. 4. 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. |
| Mask tolerance | Intraoperatively | Mask tolerance which will be measured by using mask acceptance scale (MAS). MAS score: 1. Excellent: calm, cooperative, or asleep. 2. Good: Moderate fear of the mask Manageable with reassurance. 3. Fair: Cries, combative and needs restraining. 4. 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. |
| Degree of pain | 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. |
| Total postoperative analgesics consumption | Before home discharge (Up to 6 hours) | Total postoperative analgesics consumption will be recorded. |
Countries
Egypt
Contacts
CONTACTAmany A Eid, MSc
Outcome results
None listed