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Agitation | Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Agitation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Agitation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ketamine500 mg of intramuscular ketamine for severe pre-hospital agitation

Drug:HaloperidolHaloperidol 10 mg intramuscular for severe prehospital agitation.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Withdrawn

Start Date: April 2014

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

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.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Hennepin Healthcare Research Institute.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02103881

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