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More info
You can access this
clinical trial
if you have
Bone Fractures
and you are
between 5 and 17
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).

Provided treatments

  • Drug: Ketamine and saline
Tris trial is registered with FDA with number: NCT02402868. The sponsor of the trial is Lawson Health Research Institute and it is looking for 17 volunteers for the current phase.
Official trial title:
Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial