Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490997
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : August 25, 2017
University of Western Ontario, Canada
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Fractures Drug: Ketamine only Drug: Ketamine - Propofol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double Blind Evaluation of Ketamine/Propofol vs Ketamine Alone for Pediatric Extremity Fracture Reduction
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Ketamine only arm
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

Active Comparator: 2
Ketamine-Propofol arm
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

Primary Outcome Measures :
  1. Total Sedation Time [ Time Frame: defined as the time that the first study drug was injected until the patient is fully recovered with a minimum recovery score ≥ 8 ]

Secondary Outcome Measures :
  1. Time to Recovery [ Time Frame: defined as the time interval from the last study drug given to recovery score ≥ 8 ]
  2. patient, nurse, and physician satisfaction [ Time Frame: during and immediately after sedation ]
  3. complications and adverse events [ Time Frame: during and immediately after sedation ]

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy pediatric emergency patients with isolated extremity injury requiring reduction

Exclusion Criteria:

  • Active respiratory illness
  • Seizure disorder
  • Craniofacial abnormalities
  • Allergy to soy, ketamine, or propofol
  • Hypertension
  • Significant renal, cardiovascular or neurologic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490997

Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada, N6H 5B8
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Principal Investigator: Amit P Shah, MD FCFP(EM) University of Western Ontario, Canada
Principal Investigator: Greg Mosdossy, MD, FRCPC University of Western Ontario, Canada
Principal Investigator: Michael J Rieder, MD PhD FRCPC University of Western Ontario, Canada

Responsible Party: Lawson Health Research Institute Identifier: NCT00490997     History of Changes
Other Study ID Numbers: R-07-017
IRF 044-06
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2008

Keywords provided by Lawson Health Research Institute:
emergency department

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action