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

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

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date June 14, 2007
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
The primary outcome of interest in this study will be the incidence and severity of adverse events during procedural sedation, characterized using an ordered, four-point categorical scale of airway, ventilatory and hemodynamic adverse events (none, mild,
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2006)
  • The secondary outcome measures of this study will be: the incidence and type of individual adverse events listed in the primary outcome
  • the dose of propofol administered during the procedure
  • 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)
  • successful completion of the procedure
  • the operator's rating of the sedation
  • incidence of any adverse drug reaction
  • patient visual analogue scale (VAS) ratings of analgesia, amnesia, and general satisfaction.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2005)
  • The secondary outcome measures of this study will be:
  • 1. 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:
  • i. Beginning of procedure
  • ii. End of procedure
  • iii. Recovery of appropriate verbal response
  • iv. Emergency Department discharge
  • v. 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 VAS ratings of analgesia, amnesia, and general satisfaction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Official Title  ICMJE Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Fractures
  • Dislocations
  • Abscess
  • Anesthesia
  • Analgesia
Intervention  ICMJE Drug: ketamine
Study Arms  ICMJE Not Provided
Publications * Messenger DW, Murray HE, Dungey PE, van Vlymen J, Sivilotti ML. Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial. Acad Emerg Med. 2008 Oct;15(10):877-86. doi: 10.1111/j.1553-2712.2008.00219.x. Epub 2008 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 26, 2005)
124
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137085
Other Study ID Numbers  ICMJE PSI R04-43
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE The Physicians' Services Incorporated Foundation
Investigators  ICMJE
Principal Investigator: Marco LA Sivilotti, MD, MSc Queen's University
PRS Account Queen's University
Verification Date April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP