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Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Primary Purpose

Agitation

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketamine
Haloperidol
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation focused on measuring Agitation, Ketamine, Haloperidol, Emergency Medical Services, Feeling of restlessness, Increased motor activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ketamine

    Haloperidol

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
    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 Outcome Measures

    Number of participants 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 is intubated.
    venous pH
    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.
    serum potassium
    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.
    Total time the participant is a patient in 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 both the time the patient arrives in the Emergency Department, and when they leave the Emergency Department.
    Number of patients admitted versus number of patients discharged.
    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 lactate
    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.
    Number of patients experiencing laryngospasm.
    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.
    Number of patients experiencing dystonia.
    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.

    Full Information

    First Posted
    February 20, 2014
    Last Updated
    July 20, 2017
    Sponsor
    Hennepin Healthcare Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02103881
    Brief Title
    Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital
    Official Title
    A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hennepin Healthcare Research Institute

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agitation
    Keywords
    Agitation, Ketamine, Haloperidol, Emergency Medical Services, Feeling of restlessness, Increased motor activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketamine
    Arm Type
    Experimental
    Arm Description
    Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment.
    Arm Title
    Haloperidol
    Arm Type
    Experimental
    Arm Description
    Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketalar
    Intervention Description
    500 mg of intramuscular ketamine for severe pre-hospital agitation
    Intervention Type
    Drug
    Intervention Name(s)
    Haloperidol
    Other Intervention Name(s)
    Haldol
    Intervention Description
    Haloperidol 10 mg intramuscular for severe prehospital agitation.
    Primary Outcome Measure Information:
    Title
    Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
    Description
    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.
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Number of participants intubated.
    Description
    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.
    Time Frame
    2 hours
    Title
    venous pH
    Description
    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.
    Time Frame
    at one minutes and ten minutes post sedation
    Title
    serum potassium
    Description
    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.
    Time Frame
    at one minute and ten minutes post sedation
    Title
    Total time the participant is a patient in the Emergency Department.
    Description
    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.
    Time Frame
    2 hours
    Title
    Number of patients admitted versus number of patients discharged.
    Description
    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.
    Time Frame
    2 hours
    Title
    venous lactate
    Description
    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.
    Time Frame
    at one minute and ten minutes post sedation
    Title
    Number of patients experiencing laryngospasm.
    Description
    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.
    Time Frame
    2 hours
    Title
    Number of patients experiencing dystonia.
    Description
    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.
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

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