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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Catholic Health East.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Derek Isenberg, Catholic Health East
ClinicalTrials.gov Identifier:
NCT01501123
First received: December 27, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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

Condition Intervention
Agitation
Drug: Haloperidol
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Catholic Health East:

Primary Outcome Measures:
  • Time to sedation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Haloperidol
IM Haloperidol
Drug: Haloperidol
5mg IM
Active Comparator: Midazolam Drug: Midazolam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501123

Contacts
Contact: Derek Isenberg, MD 9043738034

Locations
United States, Pennsylvania
Mercy Catholic Medical Center Recruiting
Darby, Pennsylvania, United States, 19023
Sponsors and Collaborators
Catholic Health East
Investigators
Principal Investigator: Derek Isenberg, MD Mercy Catholic Medical Center
  More Information

No publications provided

Responsible Party: Derek Isenberg, MD, Catholic Health East
ClinicalTrials.gov Identifier: NCT01501123     History of Changes
Other Study ID Numbers: MCMC 2010-24
Study First Received: December 27, 2011
Last Updated: December 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Catholic Health East:
Time to sedation of agitated patients

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Haloperidol
Haloperidol decanoate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014