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Ketamine Versus Midazolam for Prehospital Agitation

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ClinicalTrials.gov Identifier: NCT03554915
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Study Description
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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
Agitation Other: Ketamine-based protocol Other: Midazolam-based protocol

Study Design
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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 : August 1, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : September 24, 2018

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Time from injection of drug to adequate sedation, defined as a score of +1 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 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 [ 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.

  2. Number of participants experiencing hypersalivation [ 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 experiences hypersalivation.

  3. Number of participants experiencing apnea [ 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 experiences apnea, defined as 6 seconds of absent EtCO2 waveform.

  4. Number of participants experiencing nausea/vomiting [ 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 experiences nausea/vomiting

  5. Number of participants 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.

  6. Number of participants needing rescue sedation [ 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 additional sedatives are needed in the prehospital or ED environment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is all patients over age 18 requiring chemical sedation for transport to the emergency department. Etiologies for agitation may include mental illness, substance abuse, critical illness or undetermined.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554915


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
More Information
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Publications:

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Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT03554915    
Other Study ID Numbers: HSR #17-4306
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Aberrant Motor Behavior in Dementia
Behavioral Symptoms
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents