Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | June 15, 2017 |
End Date: | October 1, 2017 |
Prospective Observational Investigation of Olanzapine Versus Haloperidol Versus Ziprasidone Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department
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 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.
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
We found this trial at
1
site
Click here to add this to my saved trials