Antiemetic treatment for acute gastroenteritis in children: an updated Cochrane systematic review with meta-analysis and mixed treatment comparison in a Bayesian framework
Abstract:ObjectiveTo assess the evidence for the safety and effectiveness of antiemetics on gastroenteritis-induced vomiting in children and adolescents.DesignSystematic review.Data SourcesThe Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE searched from 1980 to March 2012.MethodsMethods included comprehensive searches, data synthesis, meta-analysis and mixed treatment comparisons (MTC).Review methodsReference lists were checked, and missing or inconsistent data were sought from trial investigators. … Show more
“…This means that, in an ED setting, 6 out of 10 children aged 1–6 years with vomiting due to AGE and no or mild to moderate dehydration, can be successfully treated with oral rehydration solution alone, without the need for drugs. This finding is consistent with the estimates of the Cochrane review [17, 18]. …”
Section: Discussionsupporting
confidence: 92%
“…Hospital admission rates are lower in the ondansetron group vs both domperidone and placebo. Differences among groups did not reach the statistical significance of the meta-analysis (RR 0.41; 95% IC 0.29 to 0.59) [18]. In the present study, the need for observation stay to last more than six hours is statistically significantly lower in the ondansetron group compared with the domperidone and placebo groups.…”
Section: Discussioncontrasting
confidence: 65%
“…Evidence exists that ondansetron compared with placebo increases the proportion of patients with cessation of vomiting, reduces the immediate hospital admission rate and the need for IVT. However, not all of these studies evaluate first-line oral rehydration therapy (ORT) during hospital stay before the administration of the antiemetic [18], and an adequate comparative evaluation between domperidone and ondansetron is missing [4, 20]. Concerning the use of domperidone, only few studies are available with small sample sizes, low methodological quality, and inconsistent results [4, 15, 17, 18–23].…”
The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1–6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20–0.83) and domperidone (RR 0.47, 98.6% CI 0.23–0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1–6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.
“…This means that, in an ED setting, 6 out of 10 children aged 1–6 years with vomiting due to AGE and no or mild to moderate dehydration, can be successfully treated with oral rehydration solution alone, without the need for drugs. This finding is consistent with the estimates of the Cochrane review [17, 18]. …”
Section: Discussionsupporting
confidence: 92%
“…Hospital admission rates are lower in the ondansetron group vs both domperidone and placebo. Differences among groups did not reach the statistical significance of the meta-analysis (RR 0.41; 95% IC 0.29 to 0.59) [18]. In the present study, the need for observation stay to last more than six hours is statistically significantly lower in the ondansetron group compared with the domperidone and placebo groups.…”
Section: Discussioncontrasting
confidence: 65%
“…Evidence exists that ondansetron compared with placebo increases the proportion of patients with cessation of vomiting, reduces the immediate hospital admission rate and the need for IVT. However, not all of these studies evaluate first-line oral rehydration therapy (ORT) during hospital stay before the administration of the antiemetic [18], and an adequate comparative evaluation between domperidone and ondansetron is missing [4, 20]. Concerning the use of domperidone, only few studies are available with small sample sizes, low methodological quality, and inconsistent results [4, 15, 17, 18–23].…”
The use of antiemetics for vomiting in acute gastroenteritis in children is still a matter of debate. We conducted a double-blind randomized trial to evaluate whether a single oral dose of ondansetron vs domperidone or placebo improves outcomes in children with gastroenteritis. After failure of initial oral rehydration administration, children aged 1–6 years admitted for gastroenteritis to the pediatric emergency departments of 15 hospitals in Italy were randomized to receive one oral dose of ondansetron (0.15 mg/kg) or domperidone (0.5 mg/kg) or placebo. The primary outcome was the percentage of children receiving nasogastric or intravenous rehydration. A p value of 0.014 was used to indicate statistical significance (and 98.6% CI were calculated) as a result of having carried out two interim analyses. 1,313 children were eligible for the first attempt with oral rehydration solution, which was successful for 832 (63.4%); 356 underwent randomization (the parents of 125 children did not give consent): 118 to placebo, 119 to domperidone, and 119 to ondansetron. Fourteen (11.8%) needed intravenous rehydration in the ondansetron group vs 30 (25.2%) and 34 (28.8%) in the domperidone and placebo groups, respectively. Ondansetron reduced the risk of intravenous rehydration by over 50%, both vs placebo (RR 0.41, 98.6% CI 0.20–0.83) and domperidone (RR 0.47, 98.6% CI 0.23–0.97). No differences for adverse events were seen among groups. In a context of emergency care, 6 out of 10 children aged 1–6 years with vomiting due to gastroenteritis and without severe dehydration can be managed effectively with administration of oral rehydration solution alone. In children who fail oral rehydration, a single oral dose of ondansetron reduces the need for intravenous rehydration and the percentage of children who continue to vomit, thereby facilitating the success of oral rehydration. Domperidone was not effective for the symptomatic treatment of vomiting during acute gastroenteritis.
“…The return visits to ED were comparable between the study groups at the 24-hour follow-up. This trial [6] has been considered to have reported incoherent data with inflated treatment effect [14]. Pediatric viral GE is a self-limited disease [15].…”
“…[8][9][10][11] Ondansetron, an antiemetic agent that is increasingly employed in the ED to prevent emesis, 12,13 is now routinely administered to children with vomiting because of acute gastroenteritis, a common intercurrent illness in children. [8][9][10][11][14][15][16] In Europe, gastroenteritis is estimated to cause 14.1% of pediatric diabetic ketoacidosis (DKA). 17 Because ondansetron is nonsedating and is anecdotally increasingly used in children with T1DM, we sought to determine if its administration to children with T1DM presenting for ED care with vomiting because of intercurrent illness is associated with improved clinical outcomes.…”
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