Children aged 1-6 years old with suspected sensorineural hearing disorder, who are requested for Auditory brainstem response test Melatonin niosome gel Chloral hydrate Auditory brainstem response Pediatric sedation
Conditions
Interventions
The 0.25 ml of 20mg/g of melatonin niosome gel (contain 5 mg of melatonin)
was applied by trans-mucosal route (Sublingual area or mucosa between inner lip and gum)
before the participant underwent t
Active Comparator Drug,Active Comparator Drug
Melatonin niosome gel (MNG group),Chloral hydrate (CH group)
Sponsors
Faculty of medicine research grant Khon kaen university
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1) Participant aged 1-6 years old. 2) No abnormality of ear pinna, External auditory canal, Craniofacial anomalies and cleft palate (likely to develop Conductive Hearing problem) 3) No history of allergy to melatonin and chloral hydrate 4) No history of gastric ulcer 5) Not currently take Warfarin, Furosemide, Fluvoxamine, Nifedipine, Rifampicin, Fluconazole, Ketoconazole, Benzodiazepine, Quinolone, Carbamazepine and Cimetidine. 6) Not currently take other sedative agents eg. Opioid, Benzodiazepine and Barbiturate 7) No history of respiratory complication (eg. apnea or Upper Airway Obstruction) after previous sedation.
Exclusion criteria
Exclusion criteria: 1) Physical examinations are not match with ASA class I (normal healthy patient) or ASA class II (mild systemic disease, controlled reactive airway disease) 2) Abnormal Blood chemistry examination (Blood urea nitrogen, ALT, AST, ALP, total bilirubin and direct bilirubin) 3) History of cardiac arrhythmia, or currently takestricyclic antidepressant. 4) Calculated GFR < 50 ml/min/1.73m2 5) Participant who is diagnosed as cirrhosis or acute hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of the ABR test After the ABR test was terminated by audiologist Percentage of patient with success ABR test by the total number of patients in each arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Day time sleep induction after drug delivery and participants were asleep, until they woke up. sleep onset latency, sleep duration, and wake after sleep onset,Adverse events (Nausea, Vomiting, Headache, Irritability)) After drug delivery, During the ABR test, And at least 20 minute after wake up percentage of adverse events after drug delivery | — |
Countries
Thailand
Contacts
Public ContactSuphakrit Limpornpugdee
Department of otolaryngology, faculty of medicine, Khon kaen university
Outcome results
None listed