Clinical trial NCT01501123: Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
Official title: Re-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Keywords: Time to sedation of agitated patients
Lead sponsor: Catholic Health East
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Time to sedation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Darby
country: United States
facility: Mercy Catholic Medical Center
state: Pennsylvania
Study officials:
affiliation: Mercy Catholic Medical Center
name: Derek Isenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: