Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137085
Status:
COMPLETED
Last Update Posted:
2007-06-14
First Post:
2005-08-26
Brief Title:
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We the investigators at Queens 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 patientphysician 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None