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

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ClinicalTrials.gov Identifier: NCT00997321
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : March 26, 2012
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Sedation Drug: propofol Drug: Ketamine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department
Study Start Date : July 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Propofol
propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation
Drug: propofol
propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
Active Comparator: Ketamine
ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation
Drug: Ketamine
ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation



Primary Outcome Measures :
  1. Respiratory Depression (Sub-clinical and Clinical Signs) [ 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) ]
    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 :
  1. Time to Return of Baseline Mental Status [ Time Frame: 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

  2. Patient Reported Pain or Recall of the Procedure [ Time Frame: 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

  3. Depth of Sedation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997321


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation

Publications of Results:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997321     History of Changes
Other Study ID Numbers: MMRF062661
First Posted: October 19, 2009    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by Minneapolis Medical Research Foundation:
ketamine
propofol
procedural sedation
moderate procedural sedation in the ED

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action