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

The Comparison Effect of Preoperative Ondansetron and Metoclopramide in Reducing Nausea and Vomitting after Loparoscopic Cholecystectomy

Background & Objectives: Postoperative nausea and vomiting (PONV) is one of the most common complications of anesthesia and without prophylactic intervention occurs in about one-third of patients under general anesthesia. The aim of this study was to compare the efficacy of ondansetron and metoclopramide in reducing PONV after laparoscopic cholecystectomy. Methods: In this study, 90 patients undergoing laparoscopic cholecystectomy were randomly allocated into three equal groups (n =30) and in the first group 10 mg metoclopramide, in the second group 4 mg ondansetron and for placebo group 2 cc normal saline preoperatively were injected. Anesthesia complications in recovery and nausea and vomiting in recovery and 6 hours and 24 hours after surgery were evaluated. Data were analyzed by SPSS software with chi-square test and analysis of variance (ANOVA). P <0.05 was considered significant. Results: The incidence of nausea in placebo group was 66.7 %, in metoclopramide group was 43.3 % and in ondansetron group was 33.3 %. The difference only between placebo and ondansetron groups was significant (p =0.019). The incidence of vomiting in placebo group was 56.7%, in metoclopramide group was 20% and in ondansetron group was 26.7% and there was significant difference between placebo and ondansetron groups (p =0.035) and between placebo and metoclopramide groups (p =0.007), whereas there was not any significant difference between intervention groups (p =0.12). Also anti-emetic drug administration in ondansetron group (40%) in comparison with metoclopramide (63.3%) and placebo (66.7%) was lower, but this difference was not statistically significant (p = 0.07). Conclusion: For prevention of vomiting after laparoscopic cholecystectomy, both metoclopramide and ondansetron are effective. In comparing these two drugs, in preventing of nausea ondansetron is more effective than metoclopramide, whereas there was not any significant difference between two drugs in preventing of vomiting

Economic evaluation of ondansetron: Preliminary analysis using clinical trial data prior to price setting

This article has been made available through the Brunel Open Access Publishing Fund and is available from the specified link - Copyright © 1992 Macmillan Press Ltd.This study combines secondary analysis of efficacy and side-effect data from a randomised controlled trial with estimates of resource use to evaluate the likely economic effects of the new antiemetic agent ondansetron. Costs, effects and cost-effectiveness of ondansetron in the prophylaxis of acute nausea and vomiting induced by chemotherapy are assessed relative to antiemetic therapy with metoclopramide. Superior efficacy of ondansetron is quantified both in terms of significant emesis avoided and emesis management costs avoided. A simple cost analysis, with the metoclopramide dosage priced at 10 pounds, indicates that therapy with ondansetron would give equivalent net treatment costs, at a price ratio (ondansetron/metoclopramide) of 2.3 to 1. If therapeutic success is defined as the avoidance of emesis and antiemetic side-effects, then the two therapies would be equally cost-effective at a drug price ratio of 5 to 1. We conclude that, (i) economic evaluation prior to price setting is feasible and informative; (ii) such models can indicate prospective data collection priorities

The comparison effect of ondansetron and Metoclopramide in thereducing of nausea and vomitting after loparoscopic cholescistectomy

Background: Postoperative nausea and vomiting (PONV) is a side effect of anesthesia. Without prophylactic intervention, PONV by about one-third of patients (10 to 60%) under general anesthesia occurs. PONV consequences include delayed discharge from PACU (post anesthesia care unit), unpredictable hospital readmission, increasing the risk of pulmonary aspiration and significant postoperative discomfort. PONV can be more uncomfortable than postoperative pain. The aim of this study was to compare the efficacy of ondansetron and metoclopramide in reducing nausea and vomiting after laparoscopic cholecystectomy. Materials and methods: In this study, 90 patients (in Imam Khomeini Hospital in 2011) undergoing laparoscopic cholecystectomy were randomly allocated into three equal groups (n=30) and were equally under continuous intravenous anesthesia. Before induction of anesthesia ,for patients in the first group(M) 10 mg metoclopramide (increased volume to 2cc) and in the second group(O) 4 mg intravenous ondansetron (increased volume to 2 cc) and for control group (P) 2 cc normal saline were injected. Anesthesia complications and nausea and vomiting after surgery in recovery room and 6 and 24 hours after surgery were evaluated. Data collected by questionnaires and the data were extracted and analyzed by Spss software with chi-square test and analysis of variance (ANOVA). Results: The incidence of nausea in control group was 66.7 %, in metoclopramide group was 43.3 % and in ondansetron group was 33.3 %. The difference between control and intervention groups and between metoclopramide and ondansetron groups statistically significant (p=0.03 and p=0.03).The incidence of vomiting in control group was 56.7 %, in metoclopramide group was 20% and in ondansetron group was 26.7% and there was statistically significant difference between control and intervention groups and between ondansetron and metoclopramide groups (Respectively p=0.008 and p=0.01). Conclusion: For prevention of nausea and vomiting after laparoscopic cholecystectomy, both metoclopramide and ondansetron are effective, but in preventing nausea the effect of ondansetron is greater than metoclopramide , and the effect of metoclopramide in preventing vomiting is more than ondansetron

Association of ABCB1, 5-HT3B receptor and CYP2D6 genetic polymorphisms with ondansetron and metoclopramide antiemetic response in Indonesian cancer patients treated with highly emetogenic chemotherapy.

Our study shows that in Indonesian cancer patients treated with highly cytostatic emetogenic, carriership of the CTG haplotype of the ABCB1 gene is related to an increased risk of delayed chemotherapy-induced nausea and vomiting

Cisplatin-induced emesis: systematic review and meta-analysis of the ferret model and the effects of 5-HT3 receptor antagonists

PURPOSE: The ferret cisplatin emesis model has been used for ~30 years and enabled identification of clinically used anti-emetics. We provide an objective assessment of this model including efficacy of 5-HT(3) receptor antagonists to assess its translational validity. METHODS: A systematic review identified available evidence and was used to perform meta-analyses. RESULTS: Of 182 potentially relevant publications, 115 reported cisplatin-induced emesis in ferrets and 68 were included in the analysis. The majority (n = 53) used a 10 mg kg(−1) dose to induce acute emesis, which peaked after 2 h. More recent studies (n = 11) also used 5 mg kg(−1), which induced a biphasic response peaking at 12 h and 48 h. Overall, 5-HT(3) receptor antagonists reduced cisplatin (5 mg kg(−1)) emesis by 68% (45–91%) during the acute phase (day 1) and by 67% (48–86%) and 53% (38–68%, all P < 0.001), during the delayed phase (days 2, 3). In an analysis focused on the acute phase, the efficacy of ondansetron was dependent on the dosage and observation period but not on the dose of cisplatin. CONCLUSION: Our analysis enabled novel findings to be extracted from the literature including factors which may impact on the applicability of preclinical results to humans. It reveals that the efficacy of ondansetron is similar against low and high doses of cisplatin. Additionally, we showed that 5-HT(3) receptor antagonists have a similar efficacy during acute and delayed emesis, which provides a novel insight into the pharmacology of delayed emesis in the ferret

Acupressure on Zusanli (St36) and Taibai (Sp3) in Reducing Nausea for Patients with Dyspepsia at Banyumas Hospital

Background: Nausea is unpleasant sensation behind the throat and epigastrium often causing vomiting. Nausea is a major symptom in patients with dyspepsia. Typical treatments for nausea are antiemetic drugs and non-pharmacological therapy. Acupressure is a massage with finger to give stimulus at a particular point on the surface of the body. Acupressure on hand could reduce nausea in pregnant women. Purpose: The purpose of this research was to evaluate the effect of acupressure in reducing nausea for patients with dyspepsia at Banyumas hospital. Method: This research was quasi-experimental pretest-posttest control group design. The consecutive sampling technique was employed in this research with 30 subjects, 15 subjects in control and 15 subjects in intervention. In the control group received standard antiemetic drug and routine care. The intervention group was treated with acupressure Zusanli (ST 36) and Taibai (SP 3) for 30 minutes for both legs and received antiemetic drugs. Nausea was measured by Numerical Rating scale for Nausea. Data were analyzed with paired samples test and Mann Withney-U. Results: The findings show that acupressure Zusanli (ST 36) and Taibai (SP 3) for 30 minutes significantly reduced nausea in patients with dyspepsia in the intervention group (t=7.91, p=0.00) and between group (z=-2.884, p=0.01)

Cannabinoid Hyperemesis Syndrome

Legalization of marijuana use will increase the number of people who will become long-term users. A prior medical record review study in Australia, in 2004, identified 19 chronic marijuana users who entered the emergency department with recurrent vomiting associated with abdominal pain. Routine treatment of the nausea and vomiting, associated with the chronic marijuana abuse, with antiemetics is ineffective in patients with cannabinoid hyperemesis syndrome. Narcotics do not relieve the abdominal pain but may cause worsening rebound pain. The best treatment of cannabinoid hyperemesis syndrome was found to be abstinence from the recreational use of marijuana. It is important for advanced practice nurses to place cannabinoid hyperemesis syndrome in their differentials of patients presenting to the emergency department with recurrent nausea, vomiting, and abdominal pain. They need to be knowledgeable about cannabinoid hyperemesis syndrome to provide the proper management of care for this specific medical condition

Impact of chemotherapy-induced nausea and vomiting on quality of life in indonesian patients with gynecologic cancer.

Patients reported a negative impact on the QoL of delayed emesis after chemotherapy. Poor prophylaxis of patients' nausea and vomiting after chemotherapy interferes with patients' QoL. Medical and behavioral interventions may help to alleviate the negative consequences of chemotherapeutic treatment in patients with gynecologic cancers treated with suboptimal antiemetics

The effect of Ondansetron in prevention of postoperative shivering after general aesthesia in gynecological surgery

Background: Postoperative shivering is one of the common problems following general anesthesia and may lead to multiple complications. Different drugs and methods have been used in prevention and treatment of the postoperative shivering. The aim of this study was to examine the preventive effects of Ondansetron and Meperidine on postoperative shivering. Methods: This randomized placebo-controlled double blind clinical trial included 90 patients scheduled for elective gynecologic operations, randomly divided to three groups. Ondansetron (4mg), Meperidine (0.4 mg/kg) and 2 cc normal saline (as a control group) were administered immediately before the induction of anesthesia. Anesthesia induced equivalently for all. Patients were observed in terms of vital signs, side effects and shivering. Results: Postoperative shivering was observed in 13.3% of patients in Ondansetron group and 20% of Meperidine group, significantly lower than controls (50%). The reduction of core and skin temperature during the anesthesia and recovery, changes in systolic and diastolic blood pressure and heart rate were similar in all three groups. The incidence of nausea was similar among three groups of study while vomiting occurred in 6.7% of Meperidine group and 3.3 % of controls but none of the patients receiving Ondansetron. Conclusion: Administration of 4 mg ondansetron before the induction of anesthesia have significant effect on the reduction of post operative shivering. Ondansetron can be used in outpatients operation particularly in patients with cardiovascular problems because of its hemodynamic stability and reduction of nausea and vomitin