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Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

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ClinicalTrials.gov Identifier: NCT02103881
Recruitment Status : Withdrawn
First Posted : April 4, 2014
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE April 4, 2014
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS. [ Time Frame: 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 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
  • Number of participants intubated. [ Time Frame: 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.
  • venous pH [ Time Frame: at one minutes and ten minutes post sedation ]
    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 [ Time Frame: at one minute and ten minutes post sedation ]
    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. [ Time Frame: 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 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. [ Time Frame: 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 admitted or discharged.
  • venous lactate [ Time Frame: at one minute and ten minutes post sedation ]
    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. [ Time Frame: 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.
  • Number of patients experiencing dystonia. [ Time Frame: 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 dystonia occurs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital
Official Title  ICMJE A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation
Intervention  ICMJE
  • Drug: Ketamine
    500 mg of intramuscular ketamine for severe pre-hospital agitation
    Other Name: Ketalar
  • Drug: Haloperidol
    Haloperidol 10 mg intramuscular for severe prehospital agitation.
    Other Name: Haldol
Study Arms  ICMJE
  • Experimental: Ketamine
    Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment.
    Intervention: Drug: Ketamine
  • Experimental: Haloperidol
    Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment.
    Intervention: Drug: Haloperidol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2014)
210
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02103881
Other Study ID Numbers  ICMJE HSR #13-3682
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hennepin Healthcare Research Institute
Study Sponsor  ICMJE Hennepin Healthcare Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hennepin Healthcare Research Institute
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP