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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00137085
• Other Study ID Numbers: PSI R04-43
• First Posted: August 29, 2005
• Last Update Posted: June 14, 2007
• Last Verified: April 2006

Keywords provided by Queen's University:

procedural sedation

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action