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

Study Overview
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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.

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

Conditions
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Procedural Sedation

Intervention / Treatment
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* Drug: Ketamine/Midazolam
* Drug: Propofol


Participation Criteria
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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. Exclusion Criteria: Pregnant women and patients who do not meet the above criteria will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam/ketamine<br>Patients with orthopedic injuries requiring painful manipulation | Drug: Ketamine/Midazolam<br>* 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<br>|
| Active Comparator: propofol<br>Patients with orthopedic injuries requiring painful manipulation | Drug: Propofol<br>* Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural sedation and analgesia, Emergency Department, propofol versus ketamine and midazolam, painful orthopedic manipulations