search
Back to results

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

Primary Purpose

Fractures, Dislocations, Abscess

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ketamine
Sponsored by
Queen's University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures focused on measuring procedural sedation

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Queen's University

Outcomes

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.

Full Information

First Posted
August 26, 2005
Last Updated
June 13, 2007
Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00137085
Brief Title
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Official Title
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Dislocations, Abscess, Anesthesia, Analgesia
Keywords
procedural sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
124 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ketamine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary outcome measures of this study will be: the incidence and type of individual adverse events listed in the primary outcome
Title
the dose of propofol administered during the procedure
Title
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)
Title
successful completion of the procedure
Title
the operator's rating of the sedation
Title
incidence of any adverse drug reaction
Title
patient visual analogue scale (VAS) ratings of analgesia, amnesia, and general satisfaction.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco LA Sivilotti, MD, MSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18754820
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs