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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2008

Last Updated Date

July 31, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00784498 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Arm (s)

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

Completion Date

September 2009

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

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

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

Information Provided By

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

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