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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00137085
First received: August 26, 2005
Last updated: June 13, 2007
Last verified: April 2006
  Purpose

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 Intervention
Fractures
Dislocations
Abscess
Anesthesia
Analgesia
Drug: ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 124
Study Start Date: September 2004
Study Completion Date: August 2006
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.
  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137085

Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Marco LA Sivilotti, MD, MSc Queen's University
  More Information

No publications provided by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00137085     History of Changes
Other Study ID Numbers: PSI R04-43
Study First Received: August 26, 2005
Last Updated: June 13, 2007
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
procedural sedation

Additional relevant MeSH terms:
Abscess
Dislocations
Emergencies
Fractures, Bone
Suppuration
Infection
Inflammation
Pathologic Processes
Wounds and Injuries
Disease Attributes
Ketamine
Fentanyl
Propofol
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on April 15, 2014