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

Catholic Health East

Status: Completed

Conditions: Agitation

Treatments: Drug: Haloperidol; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01501123

MCMC 2010-24

Details and patient eligibility

About

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 [e-mail] or at [phone]

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Age <18
• Pregnant
• Allergic to study medication
• Transport to hospital other than Mercy Fitzgerald Hospital
• Unable to reach medical command prior to giving medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Haloperidol

Experimental group

Description:

IM Haloperidol

Treatment:

Drug: Haloperidol

IM Midazolam

Active Comparator group

Treatment:

Drug: Midazolam