Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Minneapolis Medical Research Foundation
Sponsor:
Information provided by (Responsible Party):
Jon B Cole, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT02103881
First received: February 20, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Agitation
Drug: Ketamine
Drug: Haloperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 210
Study Start Date: April 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ketamine
500 mg of intramuscular ketamine for severe pre-hospital agitation
Other Name: Ketalar
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.
Drug: Haloperidol
Haloperidol 10 mg intramuscular for severe prehospital agitation.
Other Name: Haldol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jon B Cole, Physician, Emergency Medicine, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02103881     History of Changes
Other Study ID Numbers: HSR #13-3682
Study First Received: February 20, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Minneapolis Medical Research Foundation:
Agitation
Ketamine
Haloperidol
Emergency Medical Services
Feeling of restlessness
Increased motor activity

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Ketamine
Haloperidol
Haloperidol decanoate
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on July 29, 2014