Propofol Versus Ketamine for Moderate Procedural Sedation in the Emergency Department (ED)

Study Overview
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Brief Summary
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This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.

Official Title
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Propofol Versus Ketamine for Procedural Sedation During Painful Procedures in the Emergency Department

Conditions
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Sedation

Intervention / Treatment
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* Drug: propofol
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who require moderate procedural sedation with propofol in the ED Exclusion Criteria: age > 17 years pregnant intoxicated cannot give informed consent allergy to ketamine or propofol patient will require deep procedural sedation ASA physical status score > 2

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation | Drug: propofol<br>* propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation<br>|
| Active Comparator: Ketamine<br>ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation | Drug: Ketamine<br>* ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Depression (Sub-clinical and Clinical Signs) | binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform | From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return of Baseline Mental Status | time in seconds from the first dose of medication until the patient has regained baseline mental status | from start of procedure until the return of baseline mental status up to 120 minutes | 
| Patient Reported Pain or Recall of the Procedure | patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question | single measurement immediately after patient returns to baseline mental status after sedation procedure | 
| Depth of Sedation | Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain | single measurement during sedation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, propofol, procedural sedation, moderate procedural sedation in the ED