Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department
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.
Intervention / Treatment
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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
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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
Condition or Disease
- Procedural Sedation
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 60 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Nov 01, 2008 | |
|---|---|---|
| Primary Completion: | Sep 01, 2009 | ACTUAL |
| Completion Date: | Sep 01, 2009 | ACTUAL |
| Study First Posted: | Nov 04, 2008 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 31, 2010 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
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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
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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)
More Details
| NCT Number: | NCT00784498 |
|---|---|
| Other IDs: | TASMC-08-PH-0272-CTIL |
| Study URL: | https://clinicaltrials.gov/study/NCT00784498 |
Last updated: Sep 29, 2023