Anesthesia Clinical Trial
Official title:
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
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:
- Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency
department procedural sedation, with respect to safety and efficacy parameters;
- Pilot of a blinded emergency department sedation and analgesia protocol, including drug
doses, concealment techniques, and data collection tools, to determine the feasibility
of a subsequent larger, multi-centre trial;
- Determination of the true incidence of the primary outcome measures in the study
population, using the study drug administration doses and protocol, such that an
accurate sample size may be estimated for a future, adequately-powered, multi-centre
trial;
- Validation of a newly-developed ordered, categorical rating scale for the reporting of
respiratory and hemodynamic adverse events occurring during emergency department
procedural sedation and analgesia.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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