Olanzapine Versus Midazolam for Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-18

Study Completion Date

2018-07-16

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.

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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.

Conditions

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Agitation,Psychomotor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Olanzapine

Patients receiving 10 mg IM Olanzapine per the ED protocol

Olanzapine

Intervention Type DRUG

Patients receiving Olanzapine per the ED protocol

Midazolam

Patients receiving 5 mg IM Midazolam per the ED protocol

Midazolam

Intervention Type DRUG

Patients receiving Midazolam per the ED protocol

Interventions

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Olanzapine

Patients receiving Olanzapine per the ED protocol

Intervention Type DRUG

Midazolam

Patients receiving Midazolam per the ED protocol

Intervention Type DRUG

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.