Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorTanta University
About this trial
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Parental refusal to participate in the study.
Known allergy or hypersensitivity to dexmedetomidine, melatonin or midazolam.
Presence of developmental delay.
Central nervous system disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Normal saline
DrugParticipants 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
DrugParticipants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Nebulized dexmedetomidine
DrugParticipants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Group C (Control Group)Active comparator 1 intervention
Group B: Melatonin GroupExperimental treatment 1 intervention
Group C: Dexmedetomidine GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Emergence agitation
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.
Time frame
30 minutes after recoverySecondary outcomes
1
Perioperative anxiety
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.
Time frame
During transferring to operating room (Up to 30 minutes).2
Mask tolerance
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.
Time frame
Intraoperatively3
Degree of pain
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.
Time frame
Before home discharge (Up to 6 hours)4
Total postoperative analgesics consumption
Total postoperative analgesics consumption will be recorded.
Time frame
Before home discharge (Up to 6 hours)Sponsors and contacts
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Source ClinicalTrials.gov