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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Procedural Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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midazolam/ketamine

Patients with orthopedic injuries requiring painful manipulation

Group Type ACTIVE_COMPARATOR

Ketamine/Midazolam

Intervention Type DRUG

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

Patients with orthopedic injuries requiring painful manipulation

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.