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Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Information source: Minneapolis Medical Research Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agitation

Intervention: Ketamine (Drug); Haloperidol (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Jon B Cole


This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.

Clinical Details

Official title: A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.

Secondary outcome:

Number of participants intubated.

venous pH

serum potassium

Total time the participant is a patient in the Emergency Department.

Number of patients admitted versus number of patients discharged.

venous lactate

Number of patients experiencing laryngospasm.

Number of patients experiencing dystonia.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of severe agitation in the prehospital environment

Exclusion Criteria:

- Prisoners

- Persons known to be younger than 18 years old

- Persons suspected to be younger than 18 years old

- Obviously gravid women

- Persons with profound agitation

- Persons who are unable to be transported to the treating facility

Locations and Contacts

Additional Information

Starting date: April 2014
Last updated: April 1, 2014

Page last updated: August 23, 2015

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