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

  • 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.
  • 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

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 is responsible party
Responsible Party: N/A

Participant Groups

  • 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.

  • 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

Primary Outcomes
  • 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 Outcomes
  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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