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.
Ketamine Versus Midazolam for Prehospital Agitation
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.
Intervention / Treatment
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Ketamine-based protocol (OTHER)For profoundly agitated (physically violent) patients, intramuscular ketamine 5 mg/kg will be administered first line. For severely agitated patients, intramuscular ketamine 3 mg/kg will be administered first line.
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Midazolam-based protocol (OTHER)For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.
Condition or Disease
- Agitation
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 314 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
Masking |
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Clinical Trial Dates
| Start date: | Aug 01, 2017 | ACTUAL |
|---|---|---|
| Primary Completion: | Jun 25, 2018 | ACTUAL |
| Completion Date: | Sep 24, 2018 | ACTUAL |
| Study First Posted: | Jun 13, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Apr 03, 2019 |
Sponsors / Collaborators
Lead Sponsor:
Hennepin Healthcare Research Institute
Lead sponsor is responsible party
Responsible Party:
N/A
Location
Participant Groups
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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.
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Secondary Outcomes
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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.
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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.
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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.
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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
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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.
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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.
More Details
| NCT Number: | NCT03554915 |
|---|---|
| Other IDs: | HSR #17-4306 |
| Study URL: | https://clinicaltrials.gov/study/NCT03554915 |
Last updated: Sep 29, 2023