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.

Intervention / Treatment

  • Drug: Ketamine

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

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

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