Clinical Trial: Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Re-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patie

Brief Summary:

PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)

  • The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment

  • The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1

    o The RASS is a well validated standardized score to measure a patient's agitation

  • The secondary outcomes are

    • Time until RASS returns to 0 or 1 if RASS <0
    • Need for additional sedation
    • Adverse effects (need for intubation, arrhythmia)
  • Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying haloperidol
  • Identification of potential study patients will be per state protocols
  • Exclusion Criteria for the study
  • Age <18
  • Pregnant
  • Allergic to study medication
  • Transport to hospital other than Mercy Fitzgerald Hospital
  • Unable to reach medical command prior to giving medication
  • When a paramedic identifies a possible study candidate, the paramedic will consult medical command to see if the patient is appropriate for the study
  • If the medical command agrees the patient is appropriate for the study, patients will be randomiz

    Detailed Summary:
    Sponsor: Catholic Health East

    Current Primary Outcome: Time to sedation [ Time Frame: 10 minutes ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Catholic Health East

    Dates:
    Date Received: December 27, 2011
    Date Started: November 2011
    Date Completion: December 2012
    Last Updated: December 28, 2011
    Last Verified: December 2011