Olanzapine Versus Midazolam for Agitation

Agitation,Psychomotor Clinical Trial

— OvM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03899506
• Other study ID #: HSR #18-4521
• Status: Terminated
• Start date: June 18, 2018
• Est. completion date: July 16, 2018

Study information

• Verified date: May 2019
• Source: Hennepin Healthcare Research Institute.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Psychomotor Agitation

Intervention

Drug:
• Olanzapine
Patients receiving Olanzapine per the ED protocol
• Midazolam
Patients receiving Midazolam per the ED protocol

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Adequately Sedated at 15 minutes	Proportion of patients who achieve an AMSS score of < 1 at 15 minutes	15 minutes
Secondary	Proportion of Patients Adequately Sedated at 30 minutes	Proportion of patients who achieve an AMSS score of < 1 at 30 minutes	30 minutes
Secondary	Proportion of Patients Adequately Sedated at 60 minutes	Proportion of patients who achieve an AMSS score of < 1 at 60 minutes	60 minutes
Secondary	Proportion of Patients Adequately Sedated at 120 minutes	Proportion of patients who achieve an AMSS score of < 1 at 120 minutes	120 minutes
Secondary	Safety Events	Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects	120 minutes