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

Ketamine

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.

Intervention / Treatment

  • Propofol (DRUG)
    propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
  • Ketamine (DRUG)
    ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Condition or Disease

  • Sedation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jul 01, 2007
    Primary Completion: Oct 01, 2009 ACTUAL
    Completion Date: Oct 01, 2009 ACTUAL
    Study First Posted: Oct 19, 2009 ESTIMATED
    Results First Posted: Mar 26, 2012 ESTIMATED
    Last Updated: Mar 28, 2012

    Sponsors / Collaborators

    Lead Sponsor: Hennepin Healthcare Research Institute
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Minneapolis, Minnesota, USA

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • time in seconds from the first dose of medication until the patient has regained baseline mental status

    • 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

    • Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain

    More Details

    NCT Number: NCT00997321
    Other IDs: MMRF062661
    Study URL: https://clinicaltrials.gov/study/NCT00997321
    Last updated: Sep 29, 2023