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

NCT01501123 | Completed

• 1 other identifier: MCMC 2010-24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Conditions

Agitation

Keywords

Time to sedation of agitated patients

Outcome Measures

Primary Outcomes (1)

• Time to sedation

  10 minutes

Study Arms (2)

Haloperidol

EXPERIMENTAL

IM Haloperidol

Drug: Haloperidol

IM Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Interventions

Haloperidol DRUG

5mg IM

Haloperidol

Midazolam DRUG

IM midazolam

IM Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \<18
• Pregnant
• Allergic to study medication
• Transport to hospital other than Mercy Fitzgerald Hospital
• Unable to reach medical command prior to giving medication

Sponsors & Collaborators

• Catholic Health East: lead

Study Sites (1)

Mercy Catholic Medical Center

Darby, Pennsylvania, 19023, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Haloperidol; Midazolam

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Derek Isenberg, MD

  Mercy Catholic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 29, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)