NCT03899506

Olanzapine Versus Midazolam for Agitation

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Agitation,Psychomotor

Interventions

Type	Name	Description
DRUG	Olanzapine	Patients receiving Olanzapine per the ED protocol
DRUG	Midazolam	Patients receiving Midazolam per the ED protocol

Timeline

• Start date: 2018-06-18
• Primary completion: 2018-07-16
• Completion: 2018-07-16
• First posted: 2019-04-02
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States