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

Phase 4

Completed

• Conditions: Procedural Sedation
• Interventions: Drug: Ketamine/Midazolam; Drug: Propofol

• Registration Number: NCT00784498
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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 available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-02
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2010-07-31
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam/ketamine	Ketamine/Midazolam	Patients with orthopedic injuries requiring painful manipulation
propofol	Propofol	Patients with orthopedic injuries requiring painful manipulation

Primary Outcome Measures

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

Name	Time	Method
The amnestic properties of procedural sedation with propofol versus midazolam/ketamine.	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)

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel