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Completed

NCT Number: NCT00784498

Procedural Sedation Using Propofol Versus 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.

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Key information

Conditions

Procedural Sedation Agnosia Disease Attributes Emergencies Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketamine/Midazolam

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2008
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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