Clinical trial NCT01257672: Symptomatic Treatment of Acute Gastroenteritis
Official title: Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteritis
Vomiting
Acute Gastroenteritis
Keywords: acute gastroenteritis
vomiting
ondansetron
domperidon
symptomatic treatment
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
Collaborators: name: Mario Negri Institute for Pharmacological Research
name: Agenzia Italiana del Farmaco
First posted: 2010-12-10
Enrollment: 356
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. age from 1 to 6 years;
2. presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea;
3. more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours;

Exclusion Criteria:

1. treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED;
2. underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease);
3. severe dehydration: weight loss\>10% or standardized clinical dehydration score \>=18 for children aged 12-24 months and \>=16 for older children;
4. known hypersensitivity to ondansetron or domperidone;
5. previous enrolment in the study.

Primary outcomes:
measure: Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT.
timeFrame: 6 hours
Secondary outcomes:
measure: Percentage of subjects needing hospital admission for the same illness;
timeFrame: 48 hours
measure: Percentage of subjects needing observation stay for more than 6 hours for the same illness
timeFrame: 48 hours
measure: Total emesis duration in the 3 allocation groups;
timeFrame: 48 hours
measure: Number of episodes of vomiting in the 3 treatment groups during the follow-up period
timeFrame: 48 hours
measure: Percentage of subjects presenting adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Verbania
country: Italy
facility: Dipartimento di Pediatria, Ospedale Castelli
state: Novara
city: Avellino
country: Italy
facility: Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati
city: Brescia
country: Italy
facility: Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili
city: Firenze
country: Italy
facility: Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer
city: Forlì
country: Italy
facility: Unità Operativa di Pediatria, Ospedale GB Morgagni
city: Genova
country: Italy
facility: Divisione di Emergenza Pediatrica, Istituto G. Gaslini
city: Macerata
country: Italy
facility: Dipartimento di Pediatrica, Ospedale di Macerata
city: Modena
country: Italy
facility: Dipartimento di Pediatria, Azienda Policlinico di Modena
city: Padova
country: Italy
facility: Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova
city: Parma
country: Italy
facility: Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma
city: Roma
country: Italy
facility: Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú
city: Torino
country: Italy
facility: Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita
city: Treviso
country: Italy
facility: Dipartimento di Pediatria, Ospedale di Treviso
city: Trieste
country: Italy
facility: Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo
city: Verona
country: Italy
facility: Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Federico Marchetti, MD
role: STUDY_CHAIR
affiliation: Mario Negri Institute for Pharmacological Research
name: Maurizio Bonati, MD
role: STUDY_DIRECTOR
References:
citation: Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial. BMC Pediatr. 2011 Feb 10;11:15. doi: 10.1186/1471-2431-11-15.