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

Primary Purpose

Procedural Sedation

Status

Completed

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Ketamine/Midazolam

Propofol

About this trial

This is an interventional treatment trial for Procedural Sedation focused on measuring Procedural sedation and analgesia, Emergency Department, propofol versus ketamine and midazolam, painful orthopedic manipulations

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

midazolam/ketamine

propofol

Arm Description

Patients with orthopedic injuries requiring painful manipulation

Outcomes

Primary Outcome Measures

The effectiveness and safety profile of procedural sedation using propofol versus midazolam/ketamine.

Secondary Outcome Measures

The amnestic properties of procedural sedation with propofol versus midazolam/ketamine.

Full Information

NCT ID

NCT00784498

First Posted

November 2, 2008

Last Updated

July 31, 2010

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00784498

Brief Title

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

Official Title

Procedural Sedation for Painful Orthopedic Manipulations With Propofol vs. Midazolam/Ketamine in the Adult Emergency Department

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Procedural Sedation

Keywords

Procedural sedation and analgesia, Emergency Department, propofol versus ketamine and midazolam, painful orthopedic manipulations

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

midazolam/ketamine

Arm Type

Active Comparator

Arm Description

Patients with orthopedic injuries requiring painful manipulation

Arm Title

propofol

Arm Type

Active Comparator

Arm Description

Patients with orthopedic injuries requiring painful manipulation

Intervention Type

Drug

Intervention Name(s)

Ketamine/Midazolam

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pinchas Halpern, MD

Organizational Affiliation

Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tel Aviv Sourasky Medical Center

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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