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

Sedation Clinical Trial

Official title:

Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997321
• Other study ID #: MMRF062661
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2009
• Last updated: March 28, 2012
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2012
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• propofol
propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
• Ketamine
ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miner JR, Gray RO, Bahr J, Patel R, McGill JW. Randomized clinical trial of propofol versus ketamine for procedural sedation in the emergency department. Acad Emerg Med. 2010 Jun;17(6):604-11. doi: 10.1111/j.1553-2712.2010.00776.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Depression (Sub-clinical and Clinical Signs)	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	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)	Yes
Secondary	Time to Return of Baseline Mental Status	time in seconds from the first dose of medication until the patient has regained baseline mental status	from start of procedure until the return of baseline mental status up to 120 minutes	No
Secondary	Patient Reported Pain or Recall of the 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	single measurement immediately after patient returns to baseline mental status after sedation procedure	No
Secondary	Depth of Sedation	Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain	single measurement during sedation procedure	Yes