Study Enrollment When "Preconsent" Is Utilized for a Randomized Clinical Trial of Two Treatments for Acute Agitation in the Emergency Department.

Background: Acute agitation in the emergency department (ED) represents a danger to both patients and their caregivers. Medication is often needed, and few high-quality randomized trials have evaluated the optimal drugs for this vulnerable population. In the United States, as of 2017, randomized trials of drugs typically cannot be conducted under Waiver of Consent (46 CFR 45.