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

Procedural Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784498
• Other study ID #: TASMC-08-PH-0272-CTIL
• Secondary ID: 0272-08-TLVStudy
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2008
• Last updated: July 31, 2010
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Procedural Sedation

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	No