Sniffs Drugs
Conditions
Brief summary
2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children for ophthalmic examinations than the sedative effect of 1ug/kg.
Detailed description
Dexmedetomidine is an a2-adrenergic receptor agonist that provides sedation without respiratory depression.Clinical trials have demonstrated that intranasal dexmedetomidine in a dose of 1ug/kg produces satisfactory sedation in between 53% and 57% of children at anaesthetic induction. There are also reports using higher doses of intranasal dexmedetomidine. The investigators compared the sedative effect of 1ug/kg intranasal dexmedetomidine with those of 2 ug/kg for ophthalmic examinations in children aged 2 months-10 years and hypothesised that the higher dose would produce satisfactory sedation in more children at the time of anaesthetic induction.
Interventions
DRUGintranasal dexmedetomidine
1 or 2 ug/kg of intranasal dexmedetomidine
Sponsors
Ministry of Health, China
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* Need sedation for ophthalmic examinations * Children who had failed chloral hydrate sedation, i.e.there was no evidence of sedation 30 min following administration. * With informed consent from parents
Exclusion criteria
* Children with gastroesophageal reflux * Children with nausea and vomiting * Children with apnea in the past three months * Children with recent pneumonia, exacerbation of asthma, bronchitis and upper respiratory tract infection * Children with severe arrhythmias, heart failure and cardiac structural abnormalities * Children with facial abnormalities, who is expected to be difficult with effective mask ventilation * Children with severe neurological disease * Children with moyamoya disease * Children who is allergy to For dexmedetomidine or chloral hydrate * Preterm children, weight \<2 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of participants with successful rescue sedation | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Numbers of participants with completement of ophthalmic examinations | 1 day |
Countries
China
Contacts
Primary ContactHaotian Lin
Outcome results
None listed