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RECRUITING
NCT05383495
PHASE3

Anxiolysis for Laceration Repair in Children

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexmedetomidine

Intranasal dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)

DRUG

Midazolam Nasal Spray

Intranasal midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)

DRUG

Nitrous oxide

50% nitrous oxide in 50% oxygen by face mask

Locations (1)

London Health Sciences Centre

London, Ontario, Canada