Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation
Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation
The goal of this research investigation is to conduct a prospective observational study of
 the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone
 for the treatment of acute undifferentiated agitation in the emergency department.
The ED will implement a treatment protocol as a quality improvement initiative. All patients
 requiring chemical sedation for will receive haloperidol as the initial treatment for
 agitation for 21 days, followed by ziprasidone as the initial treatment for agitation for 21
 days, followed by olanzapine as the initial treatment for agitation for 21 days, and finally
 midazolam as the initial treatment for agitation for 21 days.

 This is a clinical care quality improvement protocol. The research component is the
 observation of this clinical care protocol.

 Patients who receive medications in the ED will be observed by research staff, evaluating
 efficacy and safety of the administered medication. The decision to administer the medication
 is at the discretion of the physician. Research protocols are only such that we are observing
 the efficacy and safety, which coincides the quality improvement purposes of this clinical
 protocol.

 Trained Research Associates will collect all data on patients who receive a protocol
 medication. This will include baseline demographic data including age, gender, etiology of
 agitation (according to the treating physician, presumed at the time of medication
 administration), initial vital signs, breath alcohol level, drug screen results, pre-hospital
 medications administered, and any other laboratory data available at the time (e.g. glucose).

 Research associates will record the patient's level of agitation using a validated agitation
 scale, the Altered Mental Status (AMS scale). The AMS scale is an ordinal scale ranging from
 -4 (profoundly somnolent) to +4 (profoundly agitated), with agitation generally defined as an
 AMS scale of 2 or greater. This scale is a modified version of the Observer's Assessment of
 Alertness Scale and the Behavioral Activity Rating Scale.

 AMS scores will be recorded at the time of medication administration and at every subsequent
 15-minute interval until 120 minutes. Research associates will also carry stopwatches and
 record the time elapsed until adequate sedation (defined as an AMS ≤ 0), as well as whether
 other medications (defined as "rescue medications") were administrated for any reason and at
 what time this occurred.

 Research associates will prospectively monitor each patient for all adverse side effects of
 the medications, including hypoxia, need for airway intervention (nasal cannula, facemask,
 non-invasive positive pressure ventilation, endotracheal intubation), hypotension, cardiac
 dysrhythmias, extrapyramidal side effects, and other complications.
Inclusion Criteria:

 -  Emergency Department patients (18+) with acute undifferentiated agitation requiring
 chemical sedation at the discretion of the attending emergency physician

 Exclusion Criteria:

 -  Known pregnancy

 -  Allergy to the medication during the block

 -  Prisoner/under arrest