Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: propofol; Drug: Ketamine

• Registration Number: NCT00997321
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-12
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2012-02-22
• Status Verified: 2012-03
• Results First Posted: 2012-03-26
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients who require moderate procedural sedation with propofol in the ED

Exclusion Criteria

• age > 17 years
• pregnant
• intoxicated
• cannot give informed consent
• allergy to ketamine or propofol
• patient will require deep procedural sedation
• ASA physical status score > 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	propofol	propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation
Ketamine	Ketamine	ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation

Primary Outcome Measures

Name	Time	Method
Respiratory Depression (Sub-clinical and Clinical Signs)	From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)	binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform

Secondary Outcome Measures

Name	Time	Method
Time to Return of Baseline Mental Status	from start of procedure until the return of baseline mental status up to 120 minutes	time in seconds from the first dose of medication until the patient has regained baseline mental status
Patient Reported Pain or Recall of the Procedure	single measurement immediately after patient returns to baseline mental status after sedation procedure	patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question
Depth of Sedation	single measurement during sedation procedure	Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States