Ketamine Versus Midazolam for Prehospital Agitation

Hennepin Healthcare

Status: Completed

Conditions: Agitation

Treatments: Other: Ketamine-based protocol; Other: Midazolam-based protocol

Study type: Observational

Funder types: Other

Identifiers

NCT03554915

HSR #17-4306

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

314 participants in 2 patient groups

Ketamine-based Protocol

Description:

The first 6 month period of the study will employ a ketamine-based protocol for prehospital agitation. There will be a tiered dosing protocol based on degree of agitation.

Treatment:

Other: Ketamine-based protocol

Midazolam-based Protocol

Description:

The second 6 month period of the study will employ a midazolam-based protocol for prehospital agitation. There will again be a tiered dosing protocol based on degree of agitation.

Treatment:

Other: Midazolam-based protocol