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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: midazolam/ketamine
  • Patients with orthopedic injuries requiring painful manipulation
• Active Comparator: propofol
  • Patients with orthopedic injuries requiring painful manipulation

Primary 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
    Safety Issue?: Yes

Secondary 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)
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Tel-Aviv Sourasky Medical Center Other

Overall Clinical Trial Officials and Contacts

Pinchas Halpern, MD Principal Investigator Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00784498

Study ID Number: TASMC-08-PH-0272-CTIL

ClinicalTrials.gov Identifier: NCT00784498

Health Authority: Israel: Ministry of Health