Status:
COMPLETED
The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging
Lead Sponsor:
Guangzhou Women and Children's Medical Center
Conditions:
Aged
Drug
Eligibility:
All Genders
1-36 years
Phase:
PHASE4
Brief Summary
Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following seda...
Detailed Description
About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as fol...
Eligibility Criteria
Inclusion
- 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,
Exclusion
- known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02253199
Start Date
October 1 2014
End Date
March 1 2016
Last Update
March 29 2016
Active Locations (1)
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1
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000