Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Hennepin Healthcare

Status and phase: Withdrawn; Phase 4

Conditions: Agitation

Treatments: Drug: Ketamine; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02103881

HSR #13-3682

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Ketamine

Experimental group

Description:

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

Treatment:

Drug: Ketamine

Haloperidol

Experimental group

Description:

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

Treatment:

Drug: Haloperidol