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

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