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

Agitation research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Agitation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Haloperidol5mg IM

Drug:Midazolam

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HaloperidolIM Haloperidol

Midazolam

Study Status

Unknown status

Start Date: November 2011

Completed Date: December 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Time to sedation

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Derek Isenberg, MD

Lead Sponsor: Catholic Health East

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01501123

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