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

July 22, 2019 updated by: Derek Isenberg, Catholic Health East

Re-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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Darby, Pennsylvania, United States, 19023
        • Mercy Catholic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Haloperidol
IM Haloperidol
Drug: Haloperidol
5mg IM
ACTIVE_COMPARATOR: IM Midazolam
Drug: Midazolam
IM midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to sedation
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic Health East

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (ESTIMATE)

December 29, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCMC 2010-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Agitation

Clinical Trials on Haloperidol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe