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

Agitation Clinical Trial

— PHAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501123
• Other study ID #: MCMC 2010-24
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: July 2019
• Source: Catholic Health East
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Drug:
• Haloperidol
5mg IM
• Midazolam
IM midazolam

Locations

Country	Name	City	State
United States	Mercy Catholic Medical Center	Darby	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Catholic Health East

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sedation		10 minutes