The Characteristics and Prevalence of Agitation in an Urban County Emergency Department

Miner, James R.; Klein, Lauren R.; Cole, Jon B.; Driver, Brian E.; Moore, Johanna C.; Ho, Jeffrey D.

doi:10.1016/j.annemergmed.2018.06.001

Cited by 79 publications

(57 citation statements)

References 41 publications

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“…The UBACC was applied when the patients were clinically sober after observation in the ED but still had elevated ethanol concentrations. This observation period limits the generalizability of these findings when applied to patients presenting with acute agitation, which, in the ED, is frequently due to acute intoxication . The UBACC when subsequently applied to a larger random sample of 415 acutely intoxicated ED patients shortly after a medical screening examination on ED arrival found that only 16 of 415 (3.9%) intoxicated ED patients had capacity to consent; furthermore, of these 16 patients, eight did not recall taking the assessment once clinically sober, suggesting that consent tools have limited utility in the intoxicated, agitated ED patient .…”

Section: Discussionmentioning

confidence: 99%

“…First, while some mildly agitated patients may have capacity to consent, the preponderance of evidence suggests most agitated patients in the ED do not have capacity. A common reason is that, unlike inpatients, ED patients with acute agitation are frequently acutely intoxicated . Some have proposed the use of brief consent tools, such as the University of California at San Diego Brief Assessment of Capacity to Consent (UBACC) to mitigate this issue.…”

Section: Discussionmentioning

confidence: 99%

“…FDA's criticism of the life‐threatening nature of agitation may be a more accurate rationale for not approving an EFIC trial; the life‐threatening nature of agitation exists on a spectrum. While the most severe form of agitation, excited delirium syndrome, has an associated mortality rate of 8% to 16%, a recent prevalence study of 1,146 agitated ED patients observed no deaths in the ED . As currently written, there is a gap within the EFIC regulations for completion of randomized trials on therapies for agitation in the ED, with the possible exception of excited delirium syndrome, until the “life‐threatening” clause is revisited.…”

Section: Discussionmentioning

confidence: 99%

“…Acute agitation in the emergency department (ED) is common, representing up to 2.6% of all ED visits, and represents a danger to both patients and their caregivers . Medication is often needed to keep patients and caregivers safe while simultaneously facilitating a rapid assessment to rule out underlying critical illness .…”

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confidence: 99%

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

Cole

Klein

Mullinax

et al. 2019

Academic Emergency Medicine

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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 45.116), and Exception From Informed Consent trials (21 CFR 50.24) are limited to life-threatening conditions, are onerous, and require filing an investigational new drug application with the FDA. We sought to conduct a randomized double-dummy trial of inhaled loxapine versus intramuscular haloperidol + lorazepam for acute agitation in the ED by obtaining consent in advance ("preconsent") in patients at risk of future agitation, allowing study drug administration up to 3 years later if the patient presented with acute agitation.Objective: We sought to report the successful enrollment rate of patients preconsented at an earlier ED visit for this trial.Methods: This was an analysis of patients age 18 to 64 with bipolar I disorder or schizophrenia preconsented for enrollment in the trial (clinicaltrials.gov, NCT02877108) conducted at a single urban academic center seeing approximately 60,000 patients per year. Eligible patients were assessed for capacity to consent by trained research associates, and informed consent was obtained at an ED visit for the possibility of administering drugs for agitation within the next 3 years. In the event the patient later presented to the ED and the attending physician deemed the patient required treatment for acute agitation, preconsent was confirmed and study drug would be administered.Results: Over 67 days, 1,461 patients were screened in the ED, 269 had bipolar I or schizophrenia, 194 of whom had a contraindication to inhaled loxapine leaving 75 eligible patients; preconsent was obtained in 43 patients. Four additional patients who had not preconsented were consented for the trial in real time (three by surrogate, one patient had capacity while agitated) resulting in a total of 47 consented patients. Of these 47, a total of 12 were later removed from the study: 10 patients had unrecognized exclusion criteria for inhaled

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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

Cole

Klein

Mullinax

et al. 2019

Academic Emergency Medicine

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“…Acute, undifferentiated agitation is a commonly encountered problem in the prehospital and emergency department (ED) setting . When verbal deescalation is ineffective, pharmacologic management may be required to ensure safety for both patients and providers.…”

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confidence: 99%

Psychiatric Outcomes of Patients With Severe Agitation Following Administration of Prehospital Ketamine

Lebin

Akhavan

Hippe

et al. 2019

Academic Emergency Medicine

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Background: Ketamine is an emerging drug used in the management of undifferentiated, severe agitation in the prehospital setting. However, prior work has indicated that ketamine may exacerbate psychotic symptoms in patients with schizophrenia. The objective of this study was to describe psychiatric outcomes in patients who receive prehospital ketamine for severe agitation.Methods: This is a retrospective cohort study, conducted at two tertiary academic medical centers, utilizing chart review of patients requiring prehospital sedation for severe agitation from January 1, 2014, to June 30, 2016. Patients received either intramuscular (IM) versus intravenous (IV) ketamine or IM versus IV benzodiazepine. The primary outcome was psychiatric inpatient admission with secondary outcomes including ED psychiatric evaluation and nonpsychiatric inpatient admission. Generalized estimating equations and Fisher's exact tests were used to compare cohorts.Results: During the study period, 141 patient encounters met inclusion with 59 (42%) receiving prehospital ketamine. There were no statistically significant differences between the ketamine and benzodiazepine cohorts for psychiatric inpatient admission (6.8% vs. 2.4%, difference = 4.3%, 95% CI = -2% to 12%, p = 0.23) or ED psychiatric evaluation (8.6% vs. 15%, difference = -6.8%, 95% CI = -18% to 5%, p = 0.23). Patients with schizophrenia who received ketamine did not require psychiatric inpatient admission (17% vs. 10%, difference = 6.7%, 95% CI = -46% to 79%, p = 0.63) or ED psychiatric evaluation (17% vs. 50%, difference = -33%, 95% CI = -100% to 33%, p = 0.55) significantly more than those who received benzodiazepines, although the subgroup was small (n = 16). While there was no significant difference in the nonpsychiatric admission rate between the ketamine and benzodiazepine cohorts (35% vs. 51%, p = 0.082), nonpsychiatric admissions in the benzodiazepine cohort were largely driven by intubation (63% vs. 3.8%, difference = 59%, 95% CI = 38% to 79%, p < 0.001).Conclusions: Administration of prehospital ketamine for severe agitation was not associated with an increase in the rate of psychiatric evaluation in the emergency department or psychiatric inpatient admission when compared with benzodiazepine treatment, regardless of the patient's psychiatric history.A cute, undifferentiated agitation is a commonly encountered problem in the prehospital and emergency department (ED) setting. 1,2 When verbal deescalation is ineffective, pharmacologic management may be required to ensure safety for both patients and providers. Traditional pharmacologic treatments for From the

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Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder

Preskorn

Zeller

Citrome

et al. 2022

JAMA

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IMPORTANCEAcute agitation is common in patients with bipolar disorder and requires urgent management to relieve distress and to prevent escalation to aggressive behavior.OBJECTIVE To evaluate the effect of orally absorbed, sublingual dexmedetomidine, a selective α 2A -adrenergic receptor agonist on symptoms of acute agitation in patients with bipolar disorder.DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, double-blind, placebo-controlled trial conducted in 15 sites in the US with enrollment between February 24, 2020, and April 27, 2020, and final follow-up on May 21, 2020. A total of 380 adults with bipolar I or II disorder were randomized and 362 completed the study. INTERVENTIONS Participants were randomized to 3 groups: sublingual dexmedetomidine 180 μg (n = 127), sublingual dexmedetomidine 120 μg (n = 127), or placebo (n = 126). MAIN OUTCOMES AND MEASURESThe primary efficacy end point was the mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC) total score. The range of possible total scores is 5 (absence of agitation) to 35 (extremely severe). The secondary end point was the earliest time of a statistically significant change in PEC total score from baseline for the drug vs placebo. On the primary efficacy end point, to account for multiplicity associated with comparing 2 sublingual dexmedetomidine doses with placebo, the 2-sided significance level for each dose vs placebo was set at .025. RESULTSOf 380 patients randomized (mean age, 45.6 years; 54.8% women; and 56.1% Black individuals), 378 (99.5%) self-administered the study medication and completed the study. Baseline agitation was mild to moderate, with an overall mean PEC total score of 18.0. Two hours after taking the medication, the mean changes from baseline in PEC total score were −10.4 for sublingual dexmedetomidine 180 μg, −9.0 for sublingual dexmedetomidine 120 μg, and −4.9 for placebo. Least-square mean differences from placebo in the sublingual dexmedetomidine groups at 2 hours were −5.4 (97.5% CI, −6.6 to −4.2) for 180 μg and −4.1 (97.5% CI, −5.3 to −2.9) for 120 μg (both doses P < .001 vs placebo). Treatment effects began 20 minutes after taking the medication among patients in the sublingual dexmedetomidine groups (least-square mean difference for 180 μg, −1.1 [97.5% CI, −2.0 to −0.2]; P = .007; for 120 μg, −1.0 [97.5% CI, −1.9 to −0.1]; P = .009). Adverse events occurred in 35.7% of patients taking 180 μg of dexmedetomidine, 34.9% taking 120 μg, and 17.5% taking placebo. The most common adverse events (Ն5%) in the respective 180 μg, 120 μg, and placebo groups were somnolence (21.4% and 20.6% vs 4.8%); dry mouth (4.8% and 7.1% vs 0.8%); hypotension (6.3% and 4.8% vs 0%); and dizziness (5.6% and 5.6% vs 0.8%).CONCLUSIONS AND RELEVANCE Among patients with mild to moderate agitation associated with bipolar disorder, treatment with a sublingual film formulation of dexmedetomidine 120 μg or 180 μg, compared with placebo, resulted in significantly greater reduction in the agitation score...

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The Characteristics and Prevalence of Agitation in an Urban County Emergency Department

Cited by 79 publications

References 41 publications

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

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

Psychiatric Outcomes of Patients With Severe Agitation Following Administration of Prehospital Ketamine

Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder

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