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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00997321
First received: October 12, 2009
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Sedation
Drug: propofol
Drug: Ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 Frame: from start of procedure until the return of baseline mental status up to 120 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: single measurement immediately after patient returns to baseline mental status after sedation procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: single measurement during sedation procedure ] [ Designated as safety issue: Yes ]
    Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain


Enrollment: 100
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997321     History of Changes
Other Study ID Numbers: MMRF062661
Study First Received: October 12, 2009
Results First Received: July 20, 2011
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on October 01, 2014