Antiemetic activity of ondansetron in acute gastroenteritis. Clinical trial: oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children--a double-blind randomized study. Oral ondansetron for gastroenteritis in a pediatric emergency department. Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children. Dimenhydrinate in children with infectious gastroenteritis: a prospective, RCT. A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial.
The mechanism of nausea and vomiting associated with gastroenteritis is unknown. The role of 5-HT3 receptors in emesis associated with gastroenteritis was investigated in paediatric patients.
                A randomized, double-blind, placebo-controlled, parallel-group study was conducted in three groups of 12 patients each, receiving either a single i.v. dose of ondansetron (0.3 mg/kg), metoclopramide (0.3 mg/kg) or placebo (sterile saline). Food was restricted and oral rehydration was administered for 4 h.
                During 0-24 h, the number of emetic episodes experienced was significantly greater (P = 0.048) with placebo (mean = 5) than ondansetron (mean = 2) and the proportion of patients experiencing no emesis was significantly greater (P = 0.039) with ondansetron (58%) than placebo (17%). A numerical difference, in favour of ondansetron, was observed between ondansetron and metoclopramide groups for both of the above parameters. Fewer treatment failures were observed with ondansetron (17%) than placebo (33%) and metoclopramide (42 %). More diarrheal episodes were observed in the groups receiving anti-emetic treatment. All three treatments were well tolerated.
                Ondansetron, a 5HT3 receptor antagonist, was significantly superior to placebo in preventing emesis associated with acute gastroenteritis, in paediatric patients. Therefore, serotonin, acting through 5HT3 receptors, may play a role in this form of emesis. Vomiting as a consequence of gastroenteritis frequently occurs in children. It is still debatable whether vomiting should be treated with antiemetic drugs.
                To investigate potential beneficial effects of ondansetron in treating vomiting during acute gastroenteritis.
                A randomized, double blind, placebo-controlled trial was performed in our emergency departments. Children, aged 5 months to 8 years, were randomized to receive either ondansetron 0.2 mg/kg or placebo at 8h intervals. The primary outcome measure was the frequency of emesis during an 8-h-period after enrollment.
                A hundred and nine patients were enrolled; 54 received placebo and 55 received ondansetron. As compared with the children who received placebo, children who received ondansetron were less likely to vomit both during the first 8-h follow-up in the emergency department [relative risk (RR): 0.33, 95% CI: 0.19-0.56, NNT: 2, 95% CI: 1.6-3.5], and during the next 24-h follow-up (RR: 0.15, 95% CI: 0.07-0.33, NNT: 2, 95% CI: 1.3-2.1).
                Ondansetron may be an effective and efficient treatment that reduces the incidence of vomiting from gastroenteritis during both the first 8 h and the next 24 h, and is probably a useful adjunct to oral rehydration. Vomiting limits the success of oral rehydration in children with gastroenteritis. We conducted a double-blind trial to determine whether a single oral dose of ondansetron, an antiemetic, would improve outcomes in children with gastroenteritis.
                We enrolled 215 children 6 months through 10 years of age who were treated in a pediatric emergency department for gastroenteritis and dehydration. After being randomly assigned to treatment with orally disintegrating ondansetron tablets or placebo, the children received oral-rehydration therapy according to a standardized protocol. The primary outcome was the proportion who vomited while receiving oral rehydration. The secondary outcomes were the number of episodes of vomiting and the proportions who were treated with intravenous rehydration or hospitalized.
                As compared with children who received placebo, children who received ondansetron were less likely to vomit (14 percent vs. 35 percent; relative risk, 0.40; 95 percent confidence interval, 0.26 to 0.61), vomited less often (mean number of episodes per child, 0.18 vs. 0.65; P<0.001), had greater oral intake (239 ml vs. 196 ml, P=0.001), and were less likely to be treated by intravenous rehydration (14 percent vs. 31 percent; relative risk, 0.46; 95 percent confidence interval, 0.26 to 0.79). Although the mean length of stay in the emergency department was reduced by 12 percent in the ondansetron group, as compared with the placebo group (P=0.02), the rates of hospitalization (4 percent and 5 percent, respectively; P=1.00) and of return visits to the emergency department (19 percent and 22 percent, P=0.73) did not differ significantly between groups.
                In children with gastroenteritis and dehydration, a single dose of oral ondansetron reduces vomiting and facilitates oral rehydration and may thus be well suited for use in the emergency department.
                Copyright 2006 Massachusetts Medical Society. To compare the efficacy of intravenous ondansetron or dexamethasone compared with intravenous fluid therapy alone in children presenting to the emergency department with refractory vomiting from viral gastritis who had failed attempts at oral hydration.
                This double-blind, randomized, controlled trial was performed in a tertiary care pediatric emergency department. Children aged 6 months to 12 years presenting with more than three episodes of vomiting in the past 24 hours, mild/moderate dehydration, and failed oral hydration were included. Patients with other medical causes were excluded. Subjects were randomized to dexamethasone 1 mg/kg (15 mg maximum), ondansetron 0.15 mg/kg, or placebo (normal saline [NS], 10 mL). All subjects also received intravenous NS at 10-20 mL/kg/hr. Oral fluid tolerance was evaluated at two and four hours. Those not tolerating oral fluids at four hours were admitted. Discharged patients were evaluated at 24 and 72 hours for vomiting and repeat health care visits. The primary study outcome was hospitalization rates between the groups. Data were analyzed using chi-square test, Kruskal-Wallis test, Mantel-Haenszel test, and analysis of variance, with p < 0.05 considered significant.
                A total of 166 subjects were enrolled; data for analysis were available for 44 NS-treated patients, 46 ondansetron-treated patients, and 47 dexamethasone-treated patients. Hospital admission occurred in nine patients (20.5%) receiving placebo (NS alone), two patients (4.4%) receiving ondansetron, and seven patients (14.9%) receiving dexamethasone, with ondansetron significantly different from placebo (p = 0.02). Similarly, at two hours, more ondansetron-treated patients (39 [86.6%]) tolerated oral hydration than NS-treated patients (29 [67.4%]; relative risk, 1.28; 95% confidence interval = 1.02 to 1.68). There were no differences in number of mean episodes of vomiting or repeat visits to health care at 24 and 72 hours in the ondansetron, dexamethasone, or NS groups.
                In children with dehydration secondary to vomiting from acute viral gastritis, ondansetron with intravenous rehydration improves tolerance of oral fluids after two hours and reduces the hospital admission rate when compared with intravenous rehydration with or without dexamethasone. Vomiting is a common symptom in children with infectious gastroenteritis. It contributes to fluid loss and is a limiting factor for oral rehydration therapy. Dimenhydrinate has traditionally been used for children with gastroenteritis in countries such as Canada and Germany. We investigated the efficacy and safety of dimenhydrinate in children with acute gastroenteritis.
                We performed a prospective, randomized, placebo-controlled, multicenter trial. We randomly assigned 243 children with presumed gastroenteritis and vomiting to rectal dimenhydrinate or placebo. Children with no or mild dehydration were included. All children received oral rehydration therapy. Primary outcome was defined as weight gain within 18 to 24 hours after randomization. Secondary outcomes were number of vomiting episodes, fluid intake, parents' assessment of well-being, number of diarrheal episodes, and admission rate to hospital. We recorded potential adverse effects.
                Change of weight did not differ between children who received dimenhydrinate or placebo. The mean number of vomiting episodes between randomization and follow-up visit was 0.64 in the dimenhydrinate group and 1.36 in the placebo group. In total, 69.6% of the children in the dimenhydrinate group versus 47.4% in the placebo group were free of vomiting between randomization and the follow-up visit. Hospital admission rate, fluid intake, general well-being of the children, and potential adverse effects, including the number of diarrhea episodes, were similar in both groups.
                Dimenhydrinate reduces the frequency of vomiting in children with mild dehydration; however, the overall benefit is low, because it does not improve oral rehydration and clinical outcome. Vomiting in children suffering from acute gastroenteritis interferes with the oral rehydration process and equally frustrates parents and health care providers. Adjuncts such as promethazine and metoclopramide are less than optimally effective and are associated with side effects. Ondansetron, a 5-HT3 receptor antagonist marketed as Zofran, is a safe and effective antiemetic used extensively in oncology and postoperative patients. We evaluate the effect of the antiemetic ondansetron versus placebo on the clinical outcome of patients with vomiting from gastroenteritis in a pediatric emergency department.
                This was a randomized, prospective, double-blind clinical trial in a university-affiliated children's hospital ED. Children between the ages of 6 months and 12 years who had vomited at least 5 times during the preceding 24 hours were randomized to receive either oral ondansetron or a taste- and color-matched placebo. Oral rehydration was commenced 15 minutes later at 5 mL/min per standard oral rehydration protocols. Patients were discharged after they voided and continued standard oral rehydration at home with the introduction of a bananas, rice, applesauce, and toast (BRAT) diet after the first 24 hours. Any patient requiring admission was considered a treatment failure, and no further doses were given. Discharged patients were given 5 additional doses to be used every 8 hours, and they were contacted by telephone 24 and 48 hours after discharge to record the number of episodes of vomiting and diarrhea. The parents were also required to complete a diary of the same information, which was mailed to the investigators for confirmation of the telephone data.
                One hundred forty-five patients were enrolled, of whom 51% (n=74) were randomized to ondansetron. At baseline, age distribution, sex, and severity of illness did not differ between the ondansetron and placebo groups. During the observation period in the ED, the median number of episodes of vomiting was 0 in both groups, but the rank sum of vomiting episodes was significantly lower in the ondansetron group (P =.001). The number of episodes of emesis in the ED after enrollment ranged from 0 to 7 in the placebo group and 0 to 2 in the ondansetron group. During the 48 hours of follow-up, the median number of episodes of vomiting remained 0, with no statistically significant difference between the groups. There was no statistically significant difference in the rank sum of episodes of diarrhea in the ED between the groups (P =.622); however, during the next 48 hours, the patients in the ondansetron group had significantly more diarrhea than the placebo group. A lower proportion of patients receiving ondansetron compared with placebo required intravenous fluid therapy (P =.015). The admission rate was also lower in patients receiving ondansetron (P =.007). The revisit rate was higher in the ondansetron group compared with the placebo group (P =.047).
                Ondansetron was effective in reducing the emesis from gastroenteritis during the ED phase of oral rehydration and in lowering the rates of intravenous fluid administration and hospital admission. We hypothesize that ondansetron will facilitate oral rehydration therapy in children with acute gastritis or acute gastroenteritis and mild to moderate dehydration who fail initial oral rehydration therapy. We hypothesize that subjects receiving ondansetron will tolerate oral rehydration and that a lower proportion will require intravenous hydration than subjects receiving placebo, with a clinically important difference of at least 30% when comparing 2 groups of patients presenting to the ED with acute gastritis/acute gastroenteritis. Secondarily, we hypothesize that subjects receiving ondansetron will have a lower proportion requiring admission, fewer episodes of vomiting and diarrhea, and fewer revisits.
                This double-blind, placebo-controlled, prospective, randomized trial enrolled a convenience sample of subjects 1 to 10 years old, with acute gastritis or acute gastroenteritis, who failed oral rehydration therapy in the emergency department (ED). Subjects received a weight-based dose of ondansetron (0.15 mg/kg of the orally dissolving tablet) or placebo, and oral rehydration therapy was reattempted 30 minutes later. If a subject vomited or refused to drink, he or she was considered a failed oral rehydration therapy and received IV hydration [corrected] If a subject tolerated adequate oral rehydration therapy, he or she was discharged. Parents completed symptom diaries and were contacted by telephone for follow-up. We used the chi(2) test to compare the proportions of subjects requiring IV hydration [corrected] in each group.
                We enrolled 106 subjects: 51 received ondansetron and 55 received placebo. Eleven of 51 (21.6%; 95% confidence interval [CI] 11.3% to 35.3%) of subjects who received ondansetron required intravenous hydration and 30 of 55 (54.5%; 95% CI 40.6% to 68%) of placebo subjects required intravenous hydration (p <0.001) for a difference of 32.9% (95% CI 14.54% to 48.37%). Admission rates were 5.9% (3/51) with ondansetron and 12.7% (7/55) with placebo.
                In subjects with acute gastritis/acute gastroenteritis and mild to moderate dehydration who failed initial oral rehydration therapy, the proportion of children who received intravenous hydration was smaller in the ondansetron group than in the placebo group.