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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00784498
Other study ID # TASMC-08-PH-0272-CTIL
Secondary ID 0272-08-TLVStudy
Status Completed
Phase Phase 4
First received November 2, 2008
Last updated July 31, 2010
Start date November 2008
Est. completion date September 2009

Study information

Verified date November 2008
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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) No
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