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Completed

NCT Number: NCT00997321

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

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

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Key information

Conditions

Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2009
Registry last updated
Apr 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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