Olanzapine Versus Midazolam for Agitation (OvM)
|ClinicalTrials.gov Identifier: NCT03899506|
Recruitment Status : Terminated (Investigator Voluntary Pause)
First Posted : April 2, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment|
|Agitation,Psychomotor||Drug: Olanzapine Drug: Midazolam|
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.
|Study Type :||Observational|
|Actual Enrollment :||206 participants|
|Official Title:||Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department|
|Actual Study Start Date :||June 18, 2018|
|Actual Primary Completion Date :||July 16, 2018|
|Actual Study Completion Date :||July 16, 2018|
Patients receiving 10 mg IM Olanzapine per the ED protocol
Patients receiving Olanzapine per the ED protocol
Patients receiving 5 mg IM Midazolam per the ED protocol
Patients receiving Midazolam per the ED protocol
- Proportion of Patients Adequately Sedated at 15 minutes [ Time Frame: 15 minutes ]Proportion of patients who achieve an AMSS score of < 1 at 15 minutes
- Proportion of Patients Adequately Sedated at 30 minutes [ Time Frame: 30 minutes ]Proportion of patients who achieve an AMSS score of < 1 at 30 minutes
- Proportion of Patients Adequately Sedated at 60 minutes [ Time Frame: 60 minutes ]Proportion of patients who achieve an AMSS score of < 1 at 60 minutes
- Proportion of Patients Adequately Sedated at 120 minutes [ Time Frame: 120 minutes ]Proportion of patients who achieve an AMSS score of < 1 at 120 minutes
- Safety Events [ Time Frame: 120 minutes ]Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899506
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Lauren Klein, MD||Hennepin County Medical Center, Minneapolis|