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Ketamine/Propofol vs Ketamine Alone for Pediatric Fracture Reduction

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00490997
First received: June 21, 2007
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

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 time to recovery, complications and improved satisfaction scores compared to patients receiving Ketamine alone.


Condition Intervention Phase
Fractures
Drug: Ketamine only
Drug: Ketamine - Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • recovery time [ Time Frame: time that the last study drug was injected until the patient is fully recovered with a minimum recovery score ≥ 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time from first drug to procedure start [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
  • time from first drug injected to patient recovery [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
  • patient, nurse, and physician satisfaction [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: No ]
  • complications and adverse events [ Time Frame: during and immediately after sedation ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490997

Locations
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
Investigators
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
  More Information

Publications:
Responsible Party: Dr. Amit Shah, Division of Emergency Medicine, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00490997     History of Changes
Other Study ID Numbers: R-07-017, IRF 044-06
Study First Received: June 21, 2007
Last Updated: August 14, 2008
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
ketamine
propofol
sedation
pediatric
emergency department
fracture

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

ClinicalTrials.gov processed this record on November 27, 2014