Ketamine Versus Midazolam for Prehospital Agitation

Completed

Conditions studied: Agitation

In brief

This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. 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 are 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 a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. This study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.

Key facts

Study ID

NCT03554915

Run by

Hennepin Healthcare Research Institute

People needed

314

Starts

2017-08-01

Expected to finish

2018-09-24

Last updated by the study team

2019-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Severe agitation (AMSS +2 or +3) or profound agitation (AMSS +4) requiring chemical sedation
• Transport to Hennepin County Medical Center

You may not qualify if…

• Obviously gravid women
• Patients known or suspected to be less than 18 years of age
• Patients in which stopwatch activation, for safety reasons, is unable to occur

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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