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

NCT00137085 | Completed

• 1 other identifier: PSI R04-43
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures; Dislocations; Abscess; Anesthesia; Analgesia

Keywords

procedural sedation

Outcome Measures

Primary Outcomes (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 Outcomes (7)

• 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

Interventions

ketamine DRUG

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

• 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.

  PMID: 18754820 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations; Abscess; Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marco LA Sivilotti, MD, MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: September 1, 2004
• Study Completion: August 1, 2006
• Last Updated: June 14, 2007

Record last verified: 2006-04

Locations

CA (1)