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Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation

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: NCT00137085
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : June 14, 2007
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University

Brief Summary:
We, the investigators at Queen's University, propose to conduct a randomized, double-blind, feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency Department procedural sedation with propofol. The outcomes of interest will be safety, with respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine may be a safer and more efficacious alternative to fentanyl when used as an adjunct to propofol-assisted procedural sedation.

Condition or disease Intervention/treatment Phase
Fractures Dislocations Abscess Anesthesia Analgesia Drug: ketamine Not Applicable

Detailed Description:

This initial, single-centre feasibility study will have the following specific objectives:

  • Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency department procedural sedation, with respect to safety and efficacy parameters;
  • Pilot of a blinded emergency department sedation and analgesia protocol, including drug doses, concealment techniques, and data collection tools, to determine the feasibility of a subsequent larger, multi-centre trial;
  • Determination of the true incidence of the primary outcome measures in the study population, using the study drug administration doses and protocol, such that an accurate sample size may be estimated for a future, adequately-powered, multi-centre trial;
  • Validation of a newly-developed ordered, categorical rating scale for the reporting of respiratory and hemodynamic adverse events occurring during emergency department procedural sedation and analgesia.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Study Start Date : September 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Primary Outcome Measures :
  1. The primary outcome of interest in this study will be the incidence and severity of adverse events during procedural sedation, characterized by using an ordered, four-point categorical scale of airway, ventilatory and hemodynamic adverse events.

Secondary Outcome Measures :
  1. The secondary outcome measures of this study will be: the incidence and type of individual adverse events listed in the primary outcome
  2. the dose of propofol administered during the procedure
  3. times from study drug administration to: beginning of procedure, end of procedure, recovery of appropriate verbal response, Emergency Department discharge, incidence of any adverse event(s)
  4. successful completion of the procedure
  5. the operator's rating of the sedation
  6. incidence of any adverse drug reaction
  7. patient visual analogue scale (VAS) ratings of analgesia, amnesia, and general satisfaction.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individuals presenting or referred to the Emergency Department at Kingston General Hospital with a fracture or dislocation requiring manipulation under procedural sedation; or abscess requiring incision and drainage under procedural sedation.
  • Ability to provide informed consent according to institutional requirements.
  • Ability to comprehend and communicate in English.

Exclusion Criteria:

  • Age < 14 or > 65 years
  • Any history of significant active cardiac, pulmonary, hepatic or renal disease, as determined by patient history, chart review, or emergency physician.
  • American Society of Anesthesiology (ASA) classification greater than class II.
  • Body mass > 130 kg.
  • A history of physician-diagnosed obstructive sleep apnea.
  • Chronic use of opioids including methadone and buprenorphine.
  • A self-reported history of recent substance abuse or prior opioid dependence.
  • Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
  • A history of psychotic disorders, as reported by subjects or identified on review of the medical records.
  • A known history of allergy or sensitivity to any study medication.

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): NCT00137085

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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
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Principal Investigator: Marco LA Sivilotti, MD, MSc Queen's University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00137085    
Other Study ID Numbers: PSI R04-43
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: June 14, 2007
Last Verified: April 2006
Keywords provided by Queen's University:
procedural sedation
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action