CompletedN/Aketamine

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

NCT ID

NCT00137085

Target Enrollment

124 participants

Start Date

2004-09

Est. Completion

2006-08

About This Study

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.

Conditions Studied

FracturesDislocationsAbscessAnesthesiaAnalgesia

Interventions

•ketamine

Eligibility

Age:14 Years - 65 Years

Healthy Volunteers:No

View full 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.

Study Locations (1)

Queen's University

Kingston, Ontario, Canada