NCT01501123

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Catholic Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 [e-mail] or at [phone] 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

Type	Name	Description
DRUG	Haloperidol	5mg IM
DRUG	Midazolam	IM midazolam

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2011-12-29
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States