Status:
COMPLETED
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Lead Sponsor:
Queen's University
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Fractures
Dislocations
Eligibility:
All Genders
14-65 years
Phase:
NA
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...
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 procedu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00137085
Start Date
September 1 2004
End Date
August 1 2006
Last Update
June 14 2007
Active Locations (1)
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1
Queen's University
Kingston, Ontario, Canada, K7L 3N6