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

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00784498
First received: November 2, 2008
Last updated: July 31, 2010
Last verified: November 2008

November 2, 2008
July 31, 2010
November 2008
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00784498 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department
Procedural Sedation for Painful Orthopedic Manipulations With Propofol vs. Midazolam/Ketamine in the Adult Emergency Department

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Procedural Sedation
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00784498
TASMC-08-PH-0272-CTIL, 0272-08-TLV, Study Protocol [1] 2-Jul-08
Yes
Pinchas Halpern MD. Director of Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Pinchas Halpern, MD Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Tel-Aviv Sourasky Medical Center
November 2008

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