Anxiolysis for Laceration Repair in Children

Recruiting Phase 3 Interventional Study
Laceration of Skin Distress, Emotional
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 12
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: i) Age 2-12.99 years \[highest incidence of laceration repair\] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designat…
Contacts

Naveen Poonai, MD

5196858500

naveen.poonai@lhsc.on.ca

CONTACT