Olanzapine Versus Midazolam for Agitation

NCT03899506 | Terminated

• 1 other identifier: HSR #18-4521
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Adequately Sedated at 15 minutes

  Proportion of patients who achieve an AMSS score of \< 1 at 15 minutes

  15 minutes

Secondary Outcomes (4)

• Proportion of Patients Adequately Sedated at 30 minutes

  30 minutes

• Proportion of Patients Adequately Sedated at 60 minutes

  60 minutes

• Proportion of Patients Adequately Sedated at 120 minutes

  120 minutes

• Safety Events

  120 minutes

Study Arms (2)

Olanzapine

Patients receiving 10 mg IM Olanzapine per the ED protocol

Drug: Olanzapine

Midazolam

Patients receiving 5 mg IM Midazolam per the ED protocol

Drug: Midazolam

Interventions

Olanzapine DRUG

Patients receiving Olanzapine per the ED protocol

Olanzapine

Midazolam DRUG

Patients receiving Midazolam per the ED protocol

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ED patients with agitation who receive a medication per protocol at the discretion of ED providers

You may qualify if:

• 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.

You may not qualify if:

• Patients who are prisoners, children, will NOT have their data collected

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Olanzapine; Midazolam

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lauren Klein, MD

  Hennepin County Medical Center, Minneapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: April 2, 2019
• Study Start: June 18, 2018
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)