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Completed

NCT Number: NCT03554915

Ketamine Versus Midazolam for Prehospital Agitation

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine-based protocol

Other

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

Other

For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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