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\u27 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

Weakness and the Inability to Ambulate in a 14-Month-Old Female: A Case Report and Concise Review of Guillain-Barre Syndrome

Guillain-Barre syndrome (GBS) is an acquired disease of the peripheral nervous system which causes demyelination and leads to weakness, ataxia, and areflexia. There are a variety of forms of the syndrome, and although it is found in all age groups, it is rare in children less than two years of age. The present complaint of weakness, ataxia, or lower extremity pain in the pediatric population should cause the practitioner to consider GBS in the differential. We describe a case of a 14-month-old girl presenting with weakness and the inability to ambulate who was diagnosed with GBS. The purpose of this paper is to review the emergency medicine diagnosis and management of Guillain-Barre syndrome in children

Use of antitussive medications in acute cough in young children

Acute cough, a common complaint in young children, is often the result of a viral upper respiratory infection. Cough and cold remedies generate billions of dollars in annual sales in the United States, despite a lack of evidence of their efficacy and multiple warnings by the US Food and Drug Administration. The current article begins with the best available evidence for common over-the-counter (OTC) and prescription antitussive remedies in children. The article concludes with a discussion of the pros and cons for the use of antitussives in children with cough. In general, OTC antitussive medications should not be routinely used in children under 2 years of age. In certain cases, antitussives with minimal adverse profile and some evidence of benefit may be recommended after informed counseling

Absence of QT prolongation after administration of a 24-mg bimodal-release ondansetron pill (RHB-102)

© 2020 Elsevier Inc. Objectives: Prospective data evaluating the effect of ondansetron on the corrected QT (QTc) interval is lacking in emergency department clinical use. As part of a randomized trial of a 24-mg bimodal-release ondansetron (RHB-102) pill, we tested the effect of RHB-102 compared to placebo on QTc change. Methods: This was a planned safety outcome analysis within a multicenter, double-blind, placebo-controlled trial. The trial compared the effects of RHB-102 among patients ≥12 years who presented to 21 centers with symptoms of acute gastroenteritis. Patients with an initial baseline electrocardiogram as well as a follow-up electrocardiogram 4 h later were included in the analysis. The safety endpoint for this analysis was the change from baseline in QTc interval at 4 h, the median time at which ondansetron serum level peaks. Results: A total of 147 patients were included with a mean baseline QTc in the RHB-102 and placebo arms of 410 and 406 ms, respectively. There was no difference in the change in QTc at 4 h post-study drug administration between the RHB-102 (+4, 95% CI 1–8 ms) and placebo group (+5, 95% CI 1–9 ms). In the RHB-102 arm, 6.6% of patients had a QTc change \u3e30 ms and in the placebo arm 3.6% (p = 0.48). No patient in either arm had a QTc change \u3e60 ms after study drug administration. Conclusion: In patients with normal baseline QTc, 24-mg bimodal-release ondansetron did not prolong the QTc in comparison to placebo

Absence of QT prolongation after administration of a 24-mg bimodal-release ondansetron pill (RHB-102).

OBJECTIVES: Prospective data evaluating the effect of ondansetron on the corrected QT (QTc) interval is lacking in emergency department clinical use. As part of a randomized trial of a 24-mg bimodal-release ondansetron (RHB-102) pill, we tested the effect of RHB-102 compared to placebo on QTc change. METHODS: This was a planned safety outcome analysis within a multicenter, double-blind, placebo-controlled trial. The trial compared the effects of RHB-102 among patients ≥12 years who presented to 21 centers with symptoms of acute gastroenteritis. Patients with an initial baseline electrocardiogram as well as a follow-up electrocardiogram 4 h later were included in the analysis. The safety endpoint for this analysis was the change from baseline in QTc interval at 4 h, the median time at which ondansetron serum level peaks. RESULTS: A total of 147 patients were included with a mean baseline QTc in the RHB-102 and placebo arms of 410 and 406 ms, respectively. There was no difference in the change in QTc at 4 h post-study drug administration between the RHB-102 (+4, 95% CI 1-8 ms) and placebo group (+5, 95% CI 1-9 ms). In the RHB-102 arm, 6.6% of patients had a QTc change \u3e30 ms and in the placebo arm 3.6% (p = 0.48). No patient in either arm had a QTc change \u3e60 ms after study drug administration. CONCLUSION: In patients with normal baseline QTc, 24-mg bimodal-release ondansetron did not prolong the QTc in comparison to placebo