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Olanzapine Versus Midazolam for Agitation (OvM)

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ClinicalTrials.gov Identifier: NCT03899506
Recruitment Status : Terminated (Investigator Voluntary Pause)
First Posted : April 2, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lauren Klein, Hennepin Healthcare Research Institute.

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.

Condition or disease Intervention/treatment
Agitation,Psychomotor Drug: Olanzapine Drug: Midazolam

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.


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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Olanzapine
Patients receiving 10 mg IM Olanzapine per the ED protocol
Drug: Olanzapine
Patients receiving Olanzapine per the ED protocol

Midazolam
Patients receiving 5 mg IM Midazolam per the ED protocol
Drug: Midazolam
Patients receiving Midazolam per the ED protocol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Safety Events [ Time Frame: 120 minutes ]
    Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ED patients with agitation who receive a medication per protocol at the discretion of ED providers
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899506


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute.
Investigators
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Principal Investigator: Lauren Klein, MD Hennepin County Medical Center, Minneapolis

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Responsible Party: Lauren Klein, Principal Investigator, Hennepin Healthcare Research Institute.
ClinicalTrials.gov Identifier: NCT03899506     History of Changes
Other Study ID Numbers: HSR #18-4521
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Olanzapine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors