Clinical trial NCT03899506: Olanzapine Versus Midazolam for Agitation
Official title: Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Agitation,Psychomotor
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ED patients with agitation who receive a medication per protocol at the discretion of ED providers

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients Adequately Sedated at 15 minutes
timeFrame: 15 minutes
Secondary outcomes:
measure: Proportion of Patients Adequately Sedated at 30 minutes
timeFrame: 30 minutes
measure: Proportion of Patients Adequately Sedated at 60 minutes
timeFrame: 60 minutes
measure: Proportion of Patients Adequately Sedated at 120 minutes
timeFrame: 120 minutes
measure: Safety Events
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Lauren Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: