Clinical trial NCT03554915: Ketamine Versus Midazolam for Prehospital Agitation
Official title: Ketamine Versus Midazolam for Prehospital Agitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Agitation
Keywords: Agitation, Ketamine, Midazolam, Emergency Medical Services
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all patients over age 18 requiring chemical sedation for transport to the emergency department. Etiologies for agitation may include mental illness, substance abuse, critical illness or undetermined.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from injection of drug to adequate sedation, defined as a score of +1 or less on the AMSS
timeFrame: 2 hours
Secondary outcomes:
measure: Number of participants intubated
timeFrame: 2 hours
measure: Number of participants experiencing hypersalivation
timeFrame: 2 hours
measure: Number of participants experiencing apnea
timeFrame: 2 hours
measure: Number of participants experiencing nausea/vomiting
timeFrame: 2 hours
measure: Number of participants experiencing laryngospasm
timeFrame: 2 hours
measure: Number of participants needing rescue sedation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
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