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

Primary Purpose

Sedation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
propofol
Ketamine
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedation focused on measuring ketamine, propofol, procedural sedation, moderate procedural sedation in the ED

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol

Ketamine

Arm Description

propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation

ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Return of Baseline Mental Status
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
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
Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain

Full Information

First Posted
October 12, 2009
Last Updated
March 28, 2012
Sponsor
Hennepin Healthcare Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00997321
Brief Title
Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)
Official Title
Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation
Keywords
ketamine, propofol, procedural sedation, moderate procedural sedation in the ED

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation
Primary Outcome Measure Information:
Title
Respiratory Depression (Sub-clinical and Clinical Signs)
Description
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
Time Frame
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)
Secondary Outcome Measure Information:
Title
Time to Return of Baseline Mental Status
Description
time in seconds from the first dose of medication until the patient has regained baseline mental status
Time Frame
from start of procedure until the return of baseline mental status up to 120 minutes
Title
Patient Reported Pain or Recall of the Procedure
Description
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
Time Frame
single measurement immediately after patient returns to baseline mental status after sedation procedure
Title
Depth of Sedation
Description
Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain
Time Frame
single measurement during sedation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Miner, MD
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20624140
Citation
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.
Results Reference
result

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

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