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

Study Overview
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Brief Summary
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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

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haloperidol<br>IM Haloperidol | Drug: Haloperidol<br>* 5mg IM<br>|
| Active Comparator: IM Midazolam<br> | Drug: Midazolam<br>* IM midazolam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sedation |  | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time to sedation of agitated patients