Status:
UNKNOWN
Determining the Pharmacogenetic Basis of Non-responsiveness to the Sedative Effects of Dexmedetomidine in Children
Lead Sponsor:
Hong Kong Children's Hospital
Conditions:
Pharmacogenetic Study
Procedural Anxiety
Eligibility:
All Genders
6-12 years
Brief Summary
Intranasal Dexmedetomidine is one of the sedative drugs of choice commonly used as an anxiolytic premedication for children for diagnostic or therapeutic procedures. However, some children do not achi...
Detailed Description
For most children, having to endure a diagnostic or therapeutic procedure in a hospital environment is a frightening and distressing experience, especially if it is accompanied by pain or discomfort. ...
Eligibility Criteria
Inclusion
- Children who would receive 3mcg/kg intranasal Precedex as a first line sedative agent for radiological procedures or for pre-anaesthesia sedation
- Written informed consent from parent or legal guardian
Exclusion
- Known allergy or hypersensitivity to Precedex
- Pre-existing developmental delay
- Neurological impairment
- Autism
- Fever (temperature \>/= 38.5c)
- Major organ dysfunction
- Cardiac arrhythmia
- Cardiac failure
- Subjects who would require a dose exceeding 100mcg if 3mcg/kg dose is achieved
- Subjects who have failed intranasal administration of Dexmedetomidine
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04471402
Start Date
July 20 2020
End Date
December 31 2022
Last Update
March 16 2022
Active Locations (1)
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1
Hong Kong Children's Hospital
Hong Kong, Hong Kong