drugset / Trial / NCT02402868

Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children

NCT02402868

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

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 1 mg/kg Intravenous
Subject Ketamine Small molecule 8 mg/kg Intravenous