Anxiolysis for Laceration Repair in Children

Phase 3 Recruiting 300 enrolled London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2023-12-19
Primary completion: 2025-12-31
Completion: 2026-12-31

Publications

Jiang A, Poonai N, Arthur-Hayward V, Heath A. Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE). Trials. 2025 Aug 7;26(1):280. doi: 10.1186/s13063-025-09009-z.
Poonai N, Arthur-Hayward V, Ali S, Sabhaney V, Doan Q, Trottier E, Gravel J, Tran NA, Bhatt M, Eltorki M, Thull-Freedman J, Leung J, Beer D, Jiang A, Poolacherla R, Heath A. Anxiolysis for laceration repair in children: study protocol for an open-label multicenter adaptive trial (ALICE). PLoS One. 2025 Jun 4;20(6):e0324515. doi: 10.1371/journal.pone.0324515. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	3 ug/kg	Intranasal
Subject	Midazolam	Small molecule	0.4 mg/kg	Intranasal
Subject	Nitrous Oxide	Other / unclassified	50 %	Inhaled

Indications

No indication recorded.