A Prospective Observational Study of Patients Receiving Intravenous and Intramuscular Olanzapine in the Emergency Department

Cole, Jon B.; Moore, Johanna C.; Dolan, Benjamin J.; O’Brien-Lambert, Alex; Fryza, Brandon J.; Miner, James R.; Martel, Marc L.

doi:10.1016/j.annemergmed.2016.08.008

Cited by 46 publications

(49 citation statements)

References 22 publications

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“…We believe that collection of additional cases may allow for more granular analysis of treatment effectiveness between NPS drug classes. These preliminary data regarding the effectiveness of treatments for agitation and delirium should be interpreted with caution, as effectiveness was measured by the treating physician's global satisfaction with the drug and not by a more objective measure, such as a change in agitation score or proportion of patients adequately sedated after injection . Nevertheless, the perceived effectiveness of benzodiazepines is consistent with recently published data demonstrating midazolam was superior to the injectable antipsychotics olanzapine, ziprasidone and haloperidol in terms of the proportion of patients adequately sedated 15 min after injection .…”

Section: Discussionsupporting

confidence: 82%

The Psychoactive Surveillance Consortium and Analysis Network (PSCAN): the first year

et al. 2019

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Background and aims The Psychoactive Surveillance Consortium and Analysis Network (PSCAN) is a national network of academic emergency departments (ED), analytical toxicologists and pharmacologists that collects clinical data paired with biological samples to identify and improve treatments of medical conditions arising from use of new psychoactive substances (NPS). The aim of this study was to gather clinical data with paired drug identification from NPS users who presented to EDs within PSCAN during its first year . Design Observational study involving patient records and biological samples. Setting Seven academic emergency medical centers across the United States. Participants ED patients (n = 127) > 8 years of age with possible NPS use who were identified and enrolled in PSCAN by clinical providers or research personnel. Measurements Clinical signs, symptoms and treatments were abstracted from the patients' health records. Biological samples were collected from leftover urine, serum and whole blood. Biological and drug samples, when available, were tested for drugs and drug metabolites via liquid chromatography-quadrupole time-of-flight mass spectrometry (LC-QTOF/MS). Findings Patients in whom synthetic opioids were detected (n = 9) showed higher rates of intubation (four of nine), impaired mental status (four of nine) and respiratory acidosis (five of nine) compared with the rest of the cohort (nine of 118, P-value < 0.05). Patients in whom synthetic cannabinoid (SC) were found (n = 27) had lower median diastolic blood pressures (70.5 versus 77 mmHg, P = 0.046) compared with the rest of the cohort. In 64 cases of single drug ingestion, benzodiazepines were administered in 25 cases and considered effective by the treating physician in 21 (84%) cases. Conclusions During its first year of operation, the Psychoactive Surveillance Consortium and Analysis Network captured clinical data on new classes of drugs paired with biological samples over a large geographical area in the United States. Synthetic cannabinoids were the most common new psychoactive drug identified. Synthetic opioids were associated with a high rate of intubation and respiratory acidosis.

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Section: Discussionsupporting

confidence: 82%

The Psychoactive Surveillance Consortium and Analysis Network (PSCAN): the first year

et al. 2019

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“…This is noteworthy as olanzapine use becomes more frequent for this patient population. 9 Given droperidol's rapid onset of action, 2 favorable adverse event profile, 2,3 and association with shorter ED LOS, 3 it would appear to be the antipsychotic of choice for sedating acutely agitated patients intoxicated on alcohol. Unfortunately droperidol has been largely unavailable in North America since 2013, as manufacturers report a shortage of raw ingredients.…”

Section: Discussionmentioning

confidence: 99%

“…Unfortunately droperidol has been largely unavailable in North America since 2013, as manufacturers report a shortage of raw ingredients. 9 As such, the remaining injectable immediate-release antipsychotics available to U.S. physicians include phenothiazines (chlorpromazine and fluphenazine), haloperidol, and the second-generation antipsychotics (SGAs) ziprasidone and olanzapine. Immediate-release injectable phenothiazines are essentially unstudied for acute agitation in the ED and have a far less tolerable side effect profile than butyrophenones (haloperidol and droperidol) or SGAs.…”

Section: Discussionmentioning

confidence: 99%

“…11 Torsades de pointes is far less common with SGAs, and while QTc prolongation is described with ziprasidone, 11 it does not occur with olanzapine. 9 It is arguable, however, what role at all the purported risk for torsade de pointes should play when selecting an injectable antipsychotic. The FDA "black box" warning for droperidol was precipitated largely by postmarketing surveillance data rather than peer-reviewed scientific literature, 12 and subsequent large prospective studies of high-risk patients receiving large doses of droperidol have not demonstrated cases of torsade de pointes.…”

Section: Discussionmentioning

confidence: 99%

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Parenteral Antipsychotic Choice and Its Association With Emergency Department Length of Stay for Acute Agitation Secondary to Alcohol Intoxication

Cole

Klein

Martel

2018

Academic Emergency Medicine

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“…Medication is often needed to keep patients and caregivers safe while simultaneously facilitating a rapid assessment to rule out underlying critical illness . Few high‐quality randomized trials have evaluated the optimal drug for this vulnerable population, and much of the existing evidence utilized by expert consensus panels is either retrospective or observational in nature . Thus, emergency physicians are subject to a dearth of high‐quality evidence upon which to base pharmacotherapeutic choices for agitated patients.…”

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confidence: 99%

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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A Prospective Observational Study of Patients Receiving Intravenous and Intramuscular Olanzapine in the Emergency Department

Cited by 46 publications

References 22 publications

The Psychoactive Surveillance Consortium and Analysis Network (PSCAN): the first year

The Psychoactive Surveillance Consortium and Analysis Network (PSCAN): the first year

Parenteral Antipsychotic Choice and Its Association With Emergency Department Length of Stay for Acute Agitation Secondary to Alcohol Intoxication

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

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