Ketamine Versus Midazolam for Prehospital Agitation
- Conditions
- Agitation
- Interventions
- Other: Midazolam-based protocolOther: Ketamine-based protocol
- Registration Number
- NCT03554915
- Lead Sponsor
- Hennepin Healthcare Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 314
- Age 18 or older
- Severe agitation (AMSS +2 or +3) or profound agitation (AMSS +4) requiring chemical sedation
- Transport to Hennepin County Medical Center
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Midazolam-based Protocol Midazolam-based protocol 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. Ketamine-based Protocol Ketamine-based protocol 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.
- Primary Outcome Measures
Name Time Method Time from injection of drug to adequate sedation, defined as a score of +1 or less on the AMSS 2 hours The Altered Mental Status Scale (AMSS) is an integral ordinal scale evaluating both agitation and sedation with scores from -4 to +4. It was developed at our institution and has been internally and externally validated. This scale is a modified version of the Behavioral Activity Rating Scale with additional data points from the Observer's Assessment of Alertness Scale. Effectiveness of sedation will be defined as an AMSS score less than or equal to +1.
AMSS will be determined by the treating paramedic, who will undergo training as a research associate prior to commencement of the study. Participants will be followed for the duration of agitation, an expected average of 2 hours.
- Secondary Outcome Measures
Name Time Method Number of participants intubated 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient is intubated.
Number of participants experiencing hypersalivation 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient experiences hypersalivation.
Number of participants experiencing apnea 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient experiences apnea, defined as 6 seconds of absent EtCO2 waveform.
Number of participants needing rescue sedation 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if additional sedatives are needed in the prehospital or ED environment.
Number of participants experiencing nausea/vomiting 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if the patient experiences nausea/vomiting
Number of participants experiencing laryngospasm 2 hours Participants will be followed for the duration of agitation, an expected average of 2 hours. Enrolling paramedics or research associates in the Emergency Department will record if laryngospasm occurs.
Trial Locations
- Locations (1)
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States