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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03899506
Acronym
OvM
Enrollment
206
Registered
2019-04-02
Start date
2018-06-18
Completion date
2018-07-16
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation,Psychomotor

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.

Interventions

DRUGOlanzapine

Patients receiving Olanzapine per the ED protocol

DRUGMidazolam

Patients receiving Midazolam per the ED protocol

Sponsors

Hennepin Healthcare Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Adequately Sedated at 15 minutes15 minutesProportion of patients who achieve an AMSS score of \< 1 at 15 minutes

Secondary

MeasureTime frameDescription
Proportion of Patients Adequately Sedated at 30 minutes30 minutesProportion of patients who achieve an AMSS score of \< 1 at 30 minutes
Proportion of Patients Adequately Sedated at 60 minutes60 minutesProportion of patients who achieve an AMSS score of \< 1 at 60 minutes
Proportion of Patients Adequately Sedated at 120 minutes120 minutesProportion of patients who achieve an AMSS score of \< 1 at 120 minutes
Safety Events120 minutesProportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026