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

Not Applicable

Completed

• Conditions: Agitation
• Interventions: Drug: Haloperidol; Drug: Midazolam

• Registration Number: NCT01501123
• Lead Sponsor: Catholic Health East

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol	Haloperidol	IM Haloperidol
IM Midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Time to sedation	10 minutes

Trial Locations

Locations (1)

Mercy Catholic Medical Center; 🇺🇸 Darby, Pennsylvania, United States