Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
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.
Condition or Disease
- Fractures
- Dislocations
- Abscess
- Anesthesia
- Analgesia
Phase
Study Design
| Study type: | Interventional |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 14 Years to 65 Years (Child, Adult, Older Adult) |
| Enrollment: | 124 () |
| Funded by: | Other |
Masking |
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Clinical Trial Dates
| Start date: | Sep 04, 2020 | |
|---|---|---|
| Primary Completion: | Aug 31, 2020 | |
| Completion Date: | Aug 06, 2020 | |
| Study First Posted: | Aug 29, 2005 | |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jun 14, 2007 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 14 |
| Maximum Age: | 65 |
More Details
| NCT Number: | NCT00137085 |
|---|---|
| Other IDs: | PSI R04-43 |
| Study URL: | https://ClinicalTrials.gov/show/NCT00137085 |
Last updated: Mar 18, 2021