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

NCT00784498 | Completed Phase 4 DMC

• 3 other identifiers: TASMC-08-PH-0272-CTIL0272-08-TLVStudy Protocol [1] 2-Jul-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Sedation

Keywords

Procedural sedation and analgesia; Emergency Department; propofol versus ketamine and midazolam; painful orthopedic manipulations

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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)

Study Arms (2)

midazolam/ketamine

ACTIVE COMPARATOR

Patients with orthopedic injuries requiring painful manipulation

Drug: Ketamine/Midazolam

propofol

ACTIVE COMPARATOR

Patients with orthopedic injuries requiring painful manipulation

Drug: Propofol

Interventions

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

midazolam/ketamine

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

propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women and patients who do not meet the above criteria will be excluded.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Agnosia; Emergencies

Interventions

Ketamine; Midazolam; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Pinchas Halpern, MD

  Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 2, 2008
• First Posted: November 4, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 3, 2010

Record last verified: 2008-11

Locations

IL (1)