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Anxiolysis for Laceration Repair in Children
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Summary
This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).
Official title: Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial
Key Details
Gender
All
Age Range
2 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-12-19
Completion Date
2026-12-31
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine
Intranasal dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)
Midazolam Nasal Spray
Intranasal midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)
Nitrous oxide
50% nitrous oxide in 50% oxygen by face mask
Locations (1)
London Health Sciences Centre
London, Ontario, Canada