Symptomatic Treatment of Acute Gastroenteritis
Condition: Gastroenteritis; Vomiting; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Vomiting in children with acute gastroenteritis is a major factor of failure of oral
      rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important
      reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic
      treatment of vomiting shows the efficacy of the most recently registered molecule
      (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice,
      such as domperidone, is lacking.

      The aim of this multicentre, double-blind randomized controlled trial is to compare the
      efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children
      with acute gastroenteritis who have failed Oral Rehydration Therapy.
    

Detailed description: 
      Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss
      but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who
      provide care to paediatric patients in the emergency department (ED) usually prescribe
      intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major
      symptom. Thus, effective symptomatic treatment of vomiting would lead to an important
      reduction in the use of IVT and, consequently, of the duration of hospital stay and of
      frequency of hospital admission. Available evidence on symptomatic treatment of vomiting
      shows the efficacy of the most recently registered molecule (ondansetron) but a proper
      evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is
      lacking.

      The aim of this multicentre, double-blind randomized controlled trial conducted in paediatric
      Emergency Departments is to compare the efficacy of ondansetron and domperidone for the
      symptomatic treatment of vomiting in children with AG who have failed Oral Rehydration
      Therapy.

      The trial results would provide evidence on the efficacy of domperidone, which is largely
      used in clinical practice despite the lack of proper evaluation and a controversial safety
      profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence
      supporting its efficacy in treating vomiting. The trial results would contribute to a
      reduction in the use of IVT and, consequently, in hospital admissions in children with AG.
      The design of this RCT, which closely reflect current clinical practice in EDs, will allow
      immediate transferability of results
    

Intervention name(s): Ondansetron; Domperidone; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ondansetron syrup (0,15 mg/Kg of body weight); domperidone syrup (0,5 mg/Kg of body weight); placebo
Other intervention name(s): zofran; Motilium
Intervention MeSH terms: Ondansetron; Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute gastroenteritis; vomiting; ondansetron; domperidon; symptomatic treatment