Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
Phase 3
Completed
- Conditions
- Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital
- Interventions
- Registration Number
- NCT01065701
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
- Age 1-12 years old
- American Society of Anesthesiologists (ASA) 1-2
- Elective surgery
- Children with autism or pervasive personality disorder
Exclusion Criteria
- American Society of Anaesthesiologists (ASA) 3-5
- Allergy or hypersensitive reaction to dexmedetomidine
- Known cardiac arrhythmia or congenital heart disease
- Mentally disabled
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1mcg/kg Dexmedetomidine 1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction 2mcg/kg Dexmedetomidine 2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction
- Primary Outcome Measures
Name Time Method proportion of children attained satisfactory sedation one hour
- Secondary Outcome Measures
Name Time Method time to onset of sedation one hour
Trial Locations
- Locations (1)
QUeen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong