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Ketamine Versus Midazolam for Prehospital Agitation

Sponsor
Hennepin Healthcare Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03554915
Collaborator
(none)
314
Enrollment
1
Location
13.8
Actual Duration (Months)
22.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ketamine-based protocol
  • Other: Midazolam-based protocol

Study Design

Study Type:
Observational
Actual Enrollment :
314 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ketamine Versus Midazolam for Prehospital Agitation
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Jun 25, 2018
Actual Study Completion Date :
Sep 24, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Ketamine-based protocol
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

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.

Other: Midazolam-based protocol
For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hennepin County Medical Center Minneapolis Minnesota United States 55415

Sponsors and Collaborators

  • Hennepin Healthcare Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier:
NCT03554915
Other Study ID Numbers:
  • HSR #17-4306
First Posted:
Jun 13, 2018
Last Update Posted:
Apr 5, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hennepin Healthcare Research Institute
Agitation, Ketamine, Midazolam, Emergency Medical Services
Additional relevant MeSH terms:
Psychomotor Agitation
Midazolam
Ketamine

Study Results

No Results Posted as of Apr 5, 2019