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

Tel Aviv Sourasky Medical Center

Status and phase: Completed; Phase 4

Conditions: Procedural Sedation

Treatments: Drug: Propofol; Drug: Ketamine/Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT00784498

TASMC-08-PH-0272-CTIL

Study Protocol [1] 2-Jul-08

0272-08-TLV

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

midazolam/ketamine

Active Comparator group

Description:

Patients with orthopedic injuries requiring painful manipulation

Treatment:

Drug: Ketamine/Midazolam

propofol

Active Comparator group

Description:

Patients with orthopedic injuries requiring painful manipulation

Treatment:

Drug: Propofol