Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Ketamine

Brief Summary

This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. 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 is 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 that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.

Intervention / Treatment

  • Ketamine (DRUG)
    500 mg of intramuscular ketamine for severe pre-hospital agitation
  • Haloperidol (DRUG)
    Haloperidol 10 mg intramuscular for severe prehospital agitation.

Condition or Disease

  • Agitation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2014
    Primary Completion: Jun 01, 2014 ACTUAL
    Completion Date: Jun 01, 2014 ACTUAL
    Study First Posted: Apr 04, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 20, 2017

    Sponsors / Collaborators

    Lead Sponsor: Hennepin Healthcare Research Institute
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment.

    • Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Clinical diagnosis of severe agitation in the prehospital environment

    Exclusion Criteria:

    * Prisoners
    * Persons known to be younger than 18 years old
    * Persons suspected to be younger than 18 years old
    * Obviously gravid women
    * Persons with profound agitation
    * Persons who are unable to be transported to the treating facility

    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 AMS score less than or equal to 0. 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.

    • Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for pH. Enrolling paramedics or research associates in the Emergency Department will record the data.

    • Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for potassium concentration. Enrolling paramedics or research associates in the Emergency Department will record the data.

    • 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 both the time the patient arrives in the Emergency Department, and when they leave the Emergency Department.

    • 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 admitted or discharged.

    • Venous blood will be drawn at one and ten minutes post sedation and assessed using point-of-care testing for lactate concentration. Enrolling paramedics or research associates in the Emergency Department will record the data.

    • 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 dystonia occurs.

    More Details

    NCT Number: NCT02103881
    Other IDs: HSR #13-3682
    Study URL: https://clinicaltrials.gov/study/NCT02103881
    Last updated: Sep 29, 2023