Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

500 mg of intramuscular ketamine for severe pre-hospital agitation

Haloperidol

Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment.

Group Type EXPERIMENTAL

Haloperidol

Intervention Type DRUG

Haloperidol 10 mg intramuscular for severe prehospital agitation.

Interventions

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Ketamine

500 mg of intramuscular ketamine for severe pre-hospital agitation

Intervention Type DRUG

Haloperidol

Haloperidol 10 mg intramuscular for severe prehospital agitation.

Intervention Type DRUG

Other Intervention Names

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Ketalar Haldol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No