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Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction

NCT00490997 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2017-08-25

No results posted yet for this study

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.

Conditions

  • Fractures

Interventions

DRUG

Ketamine only

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

DRUG

Ketamine - Propofol

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

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Amit P Shah, MD FCFP(EM) · Western University, Canada

  • Greg Mosdossy, MD, FRCPC · Western University, Canada

  • Michael J Rieder, MD PhD FRCPC · Western University, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490997 on ClinicalTrials.gov