At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Double Blind Evaluation of Ketamine/Propofol vs Ketamine Alone for Pediatric Extremity Fracture Reduction
In Brief
A Phase 4 clinical trial evaluating Ketamine only and Ketamine - Propofol for Fractures. Completed, enrolled 140 participants across 1 site.
Detailed Summary
The objective of this study is to compare Ketamine-Propofol with Ketamine-only in a double-blind, randomised, controlled trial in a paediatric emergency department. We believe that the combination of these two agents will provide a new and more effective option for procedural sedation in paediatric emergency department patients. The hypothesis of the study is that paediatric emergency department patients requiring procedural sedation for an isolated orthopaedic injury with Ketamine-Propofol will have reduced total sedation time, time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.
Study Details
Timeline
Interventions
Ketamine 1.0 mg/kg IV and placebo intralipid as initial sedation agents (double blinded). Ketamine .25 mg/kg IV and placebo intralipid q2 minutes prn for additional sedation
Ketamine .5 mg/kg and Propofol 1 mg/kg as initial sedation agents (double-blinded). Saline Placebo and Propofol .5 mg/kg q 2minutes for additional sedation