Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter
Status:
Terminated
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and
influenza, she participated widely in weight of winter epidemics that causes problems every
year our health care system, particularly in the pediatric emergency and inpatient since they
are the second leading cause of hospitalization in children. The main symptoms of viral acute
gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes
severe dehydration, the most common cause of hospitalization. There is no specific treatment
for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix
® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment
of acute gastroenteritis virus is symptomatic and is generally based on the use of oral
rehydration solutions (ORS) whose administration is limited by the frequent presence of
vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute
gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are
ineffective in practice, very few studies in this indication and encumbered side effects.
Several drugs have long been used in children to fight against severe vomiting associated
with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and
ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act
both on the enteric nervous system by blocking serotonin receptors. Several
placebo-controlled trials suggest that ondansetron is effective in reducing the number of
vomiting in children emergency consultant for acute gastroenteritis. However, the method used
in these tests and the number of children enrolled has not yet demonstrated the efficacy of
ondansetron on the number of admissions, the number of emergency and return the cost /
benefit ratio of this treatment. In addition, several studies reported the occurrence of
watery stools more frequently in children treated with the placebo group.
Evidence that ondansetron is well tolerated and effective for reducing the severity of
vomiting during acute gastroenteritis pediatrics winter could support the use of this
treatment in routine pediatric emergencies.
This study is a clinical trial, multicenter, controlled versus placebo whose main objective
is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children
with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after
signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria
for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron
(active) or placebo. The study does not alter the usual care of the child to the emergency
room. After passing emergency, patients will be followed in the study for 8 days, through a
phone call home to J3 and J7. The total duration of patient participation in the study is 8
days, including 4 hours emergencies (usual transit time to emergencies).