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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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.
This initial, single-centre feasibility study will have the following specific objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco LA Sivilotti, MD, MSc | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University | Kingston | Ontario | K7L 3N6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18754820 | Derived | 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. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D004204 | Joint Dislocations |
| D000038 | Abscess |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D013492 | Suppuration |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. |
| D007239 |
| Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |