Olanzapine Versus Midazolam for Agitation

Study Overview
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Brief Summary
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The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.

Detailed Description
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The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department. In the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department. The comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown. Because the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol. All patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff. This is a clinical care quality improvement protocol. The clinical protocol is not research. The research component is the observation of this clinical care protocol.

Official Title
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Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department

Conditions
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Agitation,Psychomotor

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency Department patients Patients 18 years and older Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed. Patients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication. Exclusion Criteria: - There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed. Patients who are prisoners, children, will NOT have their data collected

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Olanzapine<br>Patients receiving 10 mg IM Olanzapine per the ED protocol | Drug: Olanzapine<br>* Patients receiving Olanzapine per the ED protocol<br>|
| Midazolam<br>Patients receiving 5 mg IM Midazolam per the ED protocol | Drug: Midazolam<br>* Patients receiving Midazolam per the ED protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Adequately Sedated at 15 minutes | Proportion of patients who achieve an AMSS score of < 1 at 15 minutes | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Adequately Sedated at 30 minutes | Proportion of patients who achieve an AMSS score of < 1 at 30 minutes | 30 minutes | 
| Proportion of Patients Adequately Sedated at 60 minutes | Proportion of patients who achieve an AMSS score of < 1 at 60 minutes | 60 minutes | 
| Proportion of Patients Adequately Sedated at 120 minutes | Proportion of patients who achieve an AMSS score of < 1 at 120 minutes | 120 minutes | 
| Safety Events | Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects | 120 minutes |