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

NCT01501123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-24

No results posted yet for this study

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 [email protected] 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

Interventions

DRUG

Haloperidol

5mg IM

DRUG

Midazolam

IM midazolam

Sponsors & Collaborators

  • Catholic Health East

    lead OTHER

Principal Investigators

  • Derek Isenberg, MD · Mercy Catholic Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501123 on ClinicalTrials.gov