Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation

NCT03211897 | Completed

• 1 other identifier: HSR # 17-4345
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research investigation is to conduct a prospective observational study of the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone for the treatment of acute undifferentiated agitation in the emergency department.

Conditions

Agitation,Psychomotor

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the mean difference in Altered Mental Status (AMS) score from baseline at 15 minutes post-administration for each study drugs.

  Patients score on a previously validated agitation scale called the AMSS ADDENDUM: The primary outcome for this study was changed prior to study initiation to the proportion of patients adequately sedated at 15 minutes (defined as AMSS \< 1). This addendum was methodologically necessary to account for the ordinal, non-normal distribution of this data.

  15 minutes

Secondary Outcomes (2)

• Time to adequate sedation

  Within the 120 minutes post-medication administration

• Rescue Sedation

  1 hour

Study Arms (4)

Haloperidol 5mg Intramuscular

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive haloperidol as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Drug: Haloperidol Injection

Ziprasidone 20mg Intramuscular

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive ziprasidone as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Drug: Ziprasidone Injection

Olanzapine 10mg Intramuscular

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive olanzapine as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Drug: OLANZapine Injection

Midazolam 5mg Intramuscular

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive midazolam as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Drug: Midazolam injection

Interventions

Haloperidol Injection DRUG

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive haloperidol as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Haloperidol 5mg Intramuscular

Ziprasidone Injection DRUG

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive ziprasidone as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Ziprasidone 20mg Intramuscular

OLANZapine Injection DRUG

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive olanzapine as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Olanzapine 10mg Intramuscular

Midazolam injection DRUG

As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive midazolam as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.

Midazolam 5mg Intramuscular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Emergency Department patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician. Patients studied are from a population where agitation is predominantly due to alcohol, illicit substances, or psychiatric agitation.

You may qualify if:

• Emergency Department patients (18+) with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician

You may not qualify if:

• Known pregnancy
• Allergy to the medication during the block
• Prisoner/under arrest

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Klein LR, Driver BE, Miner JR, Martel ML, Hessel M, Collins JD, Horton GB, Fagerstrom E, Satpathy R, Cole JB. Intramuscular Midazolam, Olanzapine, Ziprasidone, or Haloperidol for Treating Acute Agitation in the Emergency Department. Ann Emerg Med. 2018 Oct;72(4):374-385. doi: 10.1016/j.annemergmed.2018.04.027. Epub 2018 Jun 7.

  PMID: 29885904 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Haloperidol; ziprasidone; 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)

Butyrophenones; Ketones; Organic Chemicals; 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: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 7, 2017
• Study Start: June 15, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)