Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial.

Importance: Vomiting resulting from acute gastroenteritis is commonly treated with intravenous antiemetics in acute care settings. If oral treatment were beneficial, patients might not need intravenous administered hydration or medication. Furthermore, a long-acting treatment could provide sustained relief from nausea and vomiting. Objective: To determine whether an experimental long-acting bimodal release ondansetron tablet decreases gastroenteritis-related vomiting and eliminates the need for intravenous therapy for 24 hours after administration. Design, Setting, and Participants: This placebo-controlled, double-blind, randomized clinical trial included patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017. Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration were randomized using a 3:2 active to placebo ratio. Analyses were performed on an intent-to-treat basis and conducted from June 1, 2017, to November 1, 2017. Intervention: Bimodal release ondansetron tablet containing 6 mg of immediate release ondansetron and 18 mg of a 24-hour release matrix for a total of 24 mg of ondansetron. Main Outcomes and Measures: Treatment success was defined as no further vomiting, no need for rescue medication, and no intravenous hydration for 24 hours after bimodal release ondansetron administration. Results: Analysis included 321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group. Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference. The proportion of treatment success was 21% higher among patients who received bimodal release ondansetron compared with those who received a placebo (relative risk, 1.21; 95% CI, 1.00-1.46; P = .04). In an analysis including only patients with a discharge diagnosis of acute gastroenteritis and no major protocol violations, there were 123 treatment successes (69.5%) in the bimodal release ondansetron group compared with 67 treatment successes (54.9%) in the placebo group (relative risk, 1.27; 95% CI, 1.05-1.53; P = .01). Adverse effects were infrequent and similar to the known safety profile of ondansetron. Conclusions and Relevance: This randomized clinical trial found that a long-acting bimodal release oral ondansetron tablet was an effective antiemetic among adolescents and adults with moderate to severe vomiting from acute gastroenteritis. The drug benefits extended to 24 hours after administration. Bimodal release ondansetron may decrease the need for intravenous access and emergency department care to manage acute gastroenteritis. Trial Registration: ClinicalTrials.gov identifier: NCT02246439.

Declared impact of the US President's statements and campaign statements on Latino populations' perceptions of safety and emergency care access.

Statements about building walls, deportation and denying services to undocumented immigrants made during President Trump's presidential campaign and presidency may induce fear in Latino populations and create barriers to their health care access. To assess how these statements relate to undocumented Latino immigrants' (UDLI) and Latino legal residents/citizens' (LLRC) perceptions of safety and their presentations for emergency care, we conducted surveys of adult patients at three county emergency departments (EDs) in California from June 2017 to December 2018. Of 1,684 patients approached, 1,337 (79.4%) agreed to participate: 34.3% UDLI, 36.9% LLRC, and 29.8% non-Latino legal residents/citizens (NLRC). The vast majority of UDLI (95%), LLRC (94%) and NLRC (85%) had heard statements about immigrants. Most UDLI (89%), LLRC (88%) and NLRC (87%) either thought that these measures were being enacted now or will be enacted in the future. Most UDLI and half of LLRC reported that these statements made them feel unsafe living in the US, 75% (95% CI 70-80%) and 51% (95% CI 47-56%), respectively. More UDLI reported that these statements made them afraid to come to the ED (24%, 95% CI 20-28%) vs LLRC (4.4%, 95% CI 3-7%) and NLRC (3.5%, 95% CI 2-6%); 55% of UDLI with this fear stated it caused them to delay coming to the ED (median delay 2-3 days). The vast majority of patients in our California EDs have heard statements during the 2016 presidential campaign or from President Trump about measures against undocumented immigrants, which have induced worry and safety concerns in both UDLI and LLRC patients. Exposure to these statements was also associated with fear of accessing emergency care in some UDLIs. Given California's sanctuary state status, these safety concerns and ED access fears may be greater in a nationwide population of Latinos.

Efficacy of a new intravenous ß2-adrenergic agonist (bedoradrine, MN-221) for patients with an acute exacerbation of asthma.

BACKGROUND: Many patients with acute exacerbation of asthma are non-responders to inhaled ß-adrenergic agonists. The goal of this study was to evaluate the safety and efficacy of intravenous bedoradrine (MN-221), a highly selective ß2-adrenergic agonist, as adjunct to standard therapy in the management of patients with acute exacerbation of asthma who did not respond to standard therapy. METHODS: Patients (N = 167) received standard therapy and were randomized to either bedoradrine (1200 µg) or placebo. Safety and efficacy parameters were monitored hourly for 3 h, followed by a 24-h follow-up visit and an 8-day follow-up phone call. Change in %FEV1 from baseline to Hour 3 was the primary outcome. Secondary outcome measures included change in %FEV1 at 1 and 2 h, change in dyspnea score at 1, 2, and 3 h, treatment failure rate, defined as a combination of hospitalization on the index visit or return to the emergency department within 1 week, and safety monitoring. RESULTS: There was no significant difference in %FEV1 at 3 h between the 2 groups. The dyspnea scores were significantly improved for patients treated with bedoradrine compared to placebo (AUC0-2 hP < 0.005, AUC0-3 hP < 0.05). The safety profile for those treated with bedoradrine was consistent with the known mechanism of action of ß-adrenergic agonists, and included both cardiovascular and metabolic effects. CONCLUSIONS: Intravenous bedoradrine, in addition to standard therapy, did not significantly increase %FEV1 at 3 h, but it was associated with significantly improved dyspnea scores. TRIAL REGISTRATION: Clinicaltrials.gov; study name: MN-221-CL-007, registration number: NCT00838591; www.clinical trials.gov.

Fear of discovery among Latino immigrants presenting to the emergency department.

OBJECTIVES: Recent legislation mandating reporting of undocumented immigrants may instill fear of discovery when they access emergency department (ED) services. The objectives of this study were to: 1) characterize the knowledge and beliefs of undocumented Latino immigrants (UDLI) about health care workers' reporting (or nonreporting) of illegal immigrants in the ED, 2) determine whether UDLI fear discovery when presenting to the ED, and 3) determine the nature and sources of this fear. METHODS: This was a cross-sectional study of UDLI and two comparison groups conducted in two California county EDs, from November 2009 to August 2010. The authors interviewed a convenience sample of adult UDLI, Latino legal residents (LLR), and non-Latino legal residents (NLLR) using a structured instrument in their native language. The main outcome was fear of discovery among UDLI and the sources of that fear. RESULTS: Of 1,224 patients approached, 1,007 (82.3%) were interviewed: 314 UDLI, 373 LLR, and 320 NLLR. The median age was 43 years (interquartile range [IQR] = 31 to 55 years), and 51% were male. UDLIs were less likely to speak English (14%, 95% confidence interval [CI] = 10% to 18%), have health insurance (39%, 95% CI 32% to 44%), or have a regular primary care provider (PCP; 39%, 95% CI = 34% to 45%), compared to LLR (English 56%, 95% CI = 51% to 61%; health insurance 50%, 95% CI = 45% to 55%; regular PCP 51%, 95% = CI 46% to 57%) and NLLR (English 95%, 95% CI = 92% to 97%; health insurance 49%, 95% CI = 43% to 54%; regular PCP 51%, 95% CI = 45% to 56%). Of the 16% of UDLI who stated that nurses and doctors treat undocumented immigrant patients differently than citizens, 41% (95% CI = 29% to 54%) reported less respect given to UDLI by staff. Thirty-two percent of UDLI had heard of Proposition 187, 13% believed hospital staff reported UDLI to immigration authorities, and 9% said they were asked about their citizenship status. Fear of coming to the hospital because of discovery was expressed by 12% (95% CI = 9% to 16%) of UDLI, with 42% (95% CI = 28% to 58%) citing discussions with friends/family, 32% (95% CI = 19% to 47%) citing media and 16% (95% CI = 7% to 30%) citing both as sources of this fear. CONCLUSIONS: One in eight of UDLI presenting to the ED express fear of discovery and consequent deportation. Belief that medical staff report UDLI and recent immigration are risk factors for this fear. Family, friends, and media are the primary sources of these concerns.

Compression ultrasonography of the lower extremity with portable vascular ultrasonography can accurately detect deep venous thrombosis in the emergency department.

STUDY OBJECTIVE: Compression ultrasonography of the lower extremity is an established method of detecting proximal lower extremity deep venous thrombosis when performed by a certified operator in a vascular laboratory. Our objective is to determine the sensitivity and specificity of bedside 2-point compression ultrasonography performed in the emergency department (ED) with portable vascular ultrasonography for the detection of proximal lower extremity deep venous thrombosis. We did this by directly comparing emergency physician-performed ultrasonography to lower extremity duplex ultrasonography performed by the Department of Radiology. METHODS: This was a prospective, cross-sectional study and diagnostic test assessment of a convenience sample of ED patients with a suspected lower extremity deep venous thrombosis, conducted at a single-center, urban, academic ED. All physicians had a 10-minute training session before enrolling patients. ED compression ultrasonography occurred before Department of Radiology ultrasonography and involved identification of 2 specific points: the common femoral and popliteal vessels, with subsequent compression of the common femoral and popliteal veins. The study result was considered positive for proximal lower extremity deep venous thrombosis if either vein was incompressible or a thrombus was visualized. Sensitivity and specificity were calculated with the final radiologist interpretation of the Department of Radiology ultrasonography as the criterion standard. RESULTS: A total of 47 physicians performed 199 2-point compression ultrasonographic examinations in the ED. Median number of examinations per physician was 2 (range 1 to 29 examinations; interquartile range 1 to 5 examinations). There were 45 proximal lower extremity deep venous thromboses observed on Department of Radiology evaluation, all correctly identified by ED 2-point compression ultrasonography. The 153 patients without proximal lower extremity deep venous thrombosis all had a negative ED compression ultrasonographic result. One patient with a negative Department of Radiology ultrasonographic result was found to have decreased compression of the popliteal vein on ED compression ultrasonography, giving a single false-positive result, yet repeated ultrasonography by the Department of Radiology 1 week later showed a popliteal deep venous thrombosis. The sensitivity and specificity of ED 2-point compression ultrasonography for deep venous thrombosis were 100% (95% confidence interval 92% to 100%) and 99% (95% confidence interval 96% to 100%), respectively. CONCLUSION: Emergency physician-performed 2-point compression ultrasonography of the lower extremity with a portable vascular ultrasonographic machine, conducted in the ED by this physician group and in this patient sample, accurately identified the presence and absence of proximal lower extremity deep venous thrombosis.

Bottoms up: methamphetamine toxicity from an unusual route.

Methamphetamine (MA) use is becoming commonplace, and emergency physicians (EPs) are seeing patients with abuse-associated complications. Previous reports have described inhalational and intravenous routes. We present the second case of rectal MA abuse in the literature. Trans-rectal use is important for EPs to consider because ongoing absorption of massive quantities may be averted upon detection. Additionally, trans-rectal abuse risks anorectal trauma and vascular necrosis with colonic perforation.

Procedural sedation in the acute care setting.

Many patients require sedation during diagnostic or therapeutic procedures. Ideally, procedural sedation minimizes the patient's awareness and discomfort while maintaining the patient's safety. Appropriate monitoring by trained personnel is the key to successful procedural sedation. These techniques should be used only by health care professionals skilled in managing complications, including cardiorespiratory compromise. It is important to take a complete history and perform a thorough physical examination, paying special attention to the selection of pharmacologic agents. Common sedative agents include etomidate, ketamine, fentanyl, and midazolam. These have become the agents of choice for procedural sedation because of their ease of use, predictable action, and excellent safety profiles. All patients requiring procedural sedation should be monitored by qualified staff at the bedside until they have recovered to an age-appropriate baseline mental status and function.

The reliability of vital sign measurements.

STUDY OBJECTIVE: Vital sign measurements, specifically heart rate, respiratory rate, and blood pressure, play a fundamental role in many medical evaluations, yet little is known about the reliability of noninvasive vital sign measurements. We sought to determine whether trained observers can reproducibly assess vital signs in the clinical setting. METHODS: Two trained observers independently measured vital signs on 140 patients presenting to an urban emergency department with acute medical complaints. Heart rate and respiratory rate were each measured by auscultation of heart and breath sounds for 1 minute. Systolic and diastolic blood pressures were determined by auscultating Korotkoff sounds while viewing pressure measurements from a standard cuff and mercury manometer. The mean value of each vital sign and Bland-Altman statistics (mean difference between observers [MDO], expected range of agreement [ERA]) were used to provide absolute and relative indices of reliability. RESULTS: The observers found a mean heart rate of 78.5 beats/min, with an MDO of 0.02 beats/min (0.03%), and an ERA of +/- 10.6 beats/min (+/- 13.5%). Respiratory rate exhibited a mean of 17.5 breaths/min, an MDO of 0.04 breaths/min (0.2%), and an ERA of +/- 6.2 breaths/min (+/- 35.5%). The mean systolic blood pressure of 127.1 mm Hg was associated with an MDO of 1.3 mm Hg (1.0%), and an ERA of +/- 24.2 mm Hg (+/- 19.0%). Diastolic blood pressure exhibited a mean of 77.4 mm Hg, an MDO of 0.3 mm Hg (0.4%) with an ERA of +/- 19.9 mm Hg (+/- 25.7%). CONCLUSION: The reproducibility of vital sign measurements may be limited by significant interobserver variability. Clinicians should recognize this inherent variability and interpret vital signs with caution.