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

NCT00997321 | Completed Phase 4 Results DMC

• 1 other identifier: MMRF062661
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Keywords

ketamine; propofol; procedural sedation; moderate procedural sedation in the ED

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (3)

• Time to Return of Baseline Mental Status

  from start of procedure until the return of baseline mental status up to 120 minutes

• Patient Reported Pain or Recall of the Procedure

  single measurement immediately after patient returns to baseline mental status after sedation procedure

• Depth of Sedation

  single measurement during sedation procedure

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: propofol

Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

propofol DRUG

propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation

Propofol

Ketamine DRUG

ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who require moderate procedural sedation with propofol in the ED

You may not qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• 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.

  PMID: 20624140 RESULT

MeSH Terms

Interventions

Propofol; Ketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Results Point of Contact

• Title: James Miner
• Organization: MinneapolisMRF

miner015@umn.edu

612-873-3000

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 19, 2009
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 2, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-03

Locations

US (1)