Clinical Trial

Anxiolysis for Laceration Repair in Children

Study acronym: ALICE
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated April 30, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2022-05-16; most recent amendment 2025-04-29.
Status change: Not Yet Recruiting → Recruiting 2023-11-20
Status change: Recruiting → Not Yet Recruiting 2023-09-26
Status change: Not Yet Recruiting → Recruiting 2023-08-16
Trial Details
NCT Number NCT05383495
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Laceration of Skin, Distress, Emotional
Enrollment 300 participants
Start Date 2023-12-19
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-30