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

Agitation Clinical Trial

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

Status Completed

Clinical Trial 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 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

• NCT number: NCT01501123
• Study type: Interventional
• Source: Catholic Health East
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Completion date: December 2015