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

• Sponsor: Catholic Health East (Other)
• Overall Status: Completed
• CT.gov ID: NCT01501123
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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 [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

Condition or Disease	Intervention/Treatment	Phase
Agitation	Drug: Haloperidol; Drug: Midazolam	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Re-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Haloperidol IM Haloperidol	Drug: Haloperidol; 5mg IM
Active Comparator: IM Midazolam	Drug: Midazolam; IM midazolam

Outcome Measures

Primary Outcome Measures

1. Time to sedation [10 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Catholic Medical Center	Darby	Pennsylvania	United States	19023

Sponsors and Collaborators

• Catholic Health East

Investigators

• Principal Investigator: Derek Isenberg, MD, Mercy Catholic Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Derek Isenberg, MD, Catholic Health East
• ClinicalTrials.gov Identifier: NCT01501123
• Other Study ID Numbers: MCMC 2010-24
• First Posted: Dec 29, 2011
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Derek Isenberg, MD, Catholic Health East: Time to sedation of agitated patients
• Additional relevant MeSH terms: Psychomotor Agitation; Midazolam; Haloperidol; Haloperidol decanoate

Study Results

No Results Posted as of Jul 24, 2019