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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784498
First Posted: November 4, 2008
Last Update Posted: August 3, 2010
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.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose

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.


Condition Intervention Phase
Procedural Sedation Drug: Ketamine/Midazolam Drug: Propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Procedural Sedation for Painful Orthopedic Manipulations With Propofol vs. Midazolam/Ketamine in the Adult Emergency Department

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 60
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: midazolam/ketamine
Patients with orthopedic injuries requiring painful manipulation
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
Active Comparator: propofol
Patients with orthopedic injuries requiring painful manipulation
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784498


Locations
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Pinchas Halpern, MD Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  More Information

Responsible Party: Pinchas Halpern MD. Director of Department of Emergency Medicine, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
ClinicalTrials.gov Identifier: NCT00784498     History of Changes
Other Study ID Numbers: TASMC-08-PH-0272-CTIL
0272-08-TLV
Study Protocol [1] 2-Jul-08
First Submitted: November 2, 2008
First Posted: November 4, 2008
Last Update Posted: August 3, 2010
Last Verified: November 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
Procedural sedation and analgesia
Emergency Department
propofol versus ketamine and midazolam
painful orthopedic manipulations

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Propofol
Midazolam
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents