drugset / Trial / NCT02402868
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
Phase 3
Completed
17 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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).
Timeline
- Start
- 2016-01
- Primary completion
- 2018-01
- Completion
- 2018-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 1 mg/kg | Intravenous |
| Subject | Ketamine | Small molecule | 8 mg/kg | Intravenous |