Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation

Anesthesia Clinical Trial

Official title: Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Analgesia
• Anesthesia
• Dislocations
• Fractures

• NCT number: NCT00137085
• Study type: Interventional
• Source: Queen's University
• Status: Completed
• Phase: N/A
• Start date: September 2004
• Completion date: August 2006