An interventional study of ketamine in Fractures, Dislocations and Abscess, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-06-14.
Sponsored by Queen's University · Not applicable, Interventional, and Treatment
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:
2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.
This study's enrollment of 124 is above the median of 68 across 1,490 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.
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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.
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.
The record gives a start of Sep 2004 and a completion of Aug 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine