Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00784498
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE November 2, 2008
First Posted Date  ICMJE November 4, 2008
Last Update Posted Date August 3, 2010
Study Start Date  ICMJE November 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
The effectiveness and safety profile of procedural sedation using propofol versus midazolam/ketamine. [ Time Frame: outcome measures will be monitored continuously and will be documented every few minutes from initiating sedation until the patient returns to his/her basic mental status ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
The amnestic properties of procedural sedation with propofol versus midazolam/ketamine. [ Time Frame: Recall issues will be assessed after the patient returns to his/her basic mental status and within 72 hours from the procedure (either on a follow up visit or by a phone call) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department
Official Title  ICMJE Procedural Sedation for Painful Orthopedic Manipulations With Propofol vs. Midazolam/Ketamine in the Adult Emergency Department
Brief Summary

The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the emergency department (ED) has become a standard of practice over the last decade. Substantial variance exists regarding usage of medication for PSA, and many anesthetic agents have been proposed for this use.

To our knowledge no head to head study compared the clinical effectiveness, safety profile and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED setting.

This prospective randomized trail can will help to evaluate the effectiveness and safety profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the discussion regarding propofol roll in the ED.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Procedural Sedation
Intervention  ICMJE
  • Drug: Ketamine/Midazolam
    Intravenous bolus of midazolam 0.1mg/kg in titrated dose of 1 mg/min until spontaneous eye closure or up to 5mg (whichever comes first) followed by ketamine 0.5-1mg/kg (up to 100mg) in titrated dose of 10mg/30 seconds, to achieve the desired level of sedation
  • Drug: Propofol
    Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation
Study Arms  ICMJE
  • Active Comparator: midazolam/ketamine
    Patients with orthopedic injuries requiring painful manipulation
    Intervention: Drug: Ketamine/Midazolam
  • Active Comparator: propofol
    Patients with orthopedic injuries requiring painful manipulation
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with orthopedic injuries requiring painful manipulation (i.e. reduction of fracture or dislocation, drainage of abscess, suture of extensive laceration)
  • Age between18-65 years
  • American Society of Anesthesiologists (ASA) score of 1 or 2
  • Systolic blood pressure higher than 90 mmHg and lower than 160 mmHg before initiating sedation
  • Willingness and ability to provide an informed consent
  • No known hypersensitivity to either medication
  • No evidence of intoxication
  • No recent heavy meal.

Exclusion Criteria:

  • Pregnant women and patients who do not meet the above criteria will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00784498
Other Study ID Numbers  ICMJE TASMC-08-PH-0272-CTIL
0272-08-TLV
Study Protocol [1] 2-Jul-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pinchas Halpern MD. Director of Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pinchas Halpern, MD Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP