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

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 randomized to
• Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)
• Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age ≥65)
• The RASS will be documented by the prehospital providers every 5 minutes until arrival at the hospital
• Once the patient arrives at the ED, the RASS will be documented in PICIS® by the emergency department nurse at the time of triage and at a minimum of hourly until the RASS =0 or 1 for 2 consecutive hours
• Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267) 205-6453

Richmond Agitation Sedation Scale

RASS RASS Description

• 4 Combative, violent, danger to staff
• 3 Pulls or removes tube(s) or catheters; aggressive
• 2 Frequent non-purposeful movement

• 1 Anxious, apprehensive, but not aggressive 0 Alert and calm

  • 1 Awakens to voice (eye opening/contact) >10 sec
  • 2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec
  • 3 Moderate sedation, movement or eye opening. No eye contact
  • 4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation
  • 5 Unarousable, no response to voice or physical stimulation