Symptomatic Treatment of Acute Gastroenteritis

Phase 3

Completed

• Conditions: Vomiting; Gastroenteritis; Acute Gastroenteritis
• Interventions: Drug: placebo; Drug: Domperidone; Drug: Ondansetron

• Registration Number: NCT01257672
• Lead Sponsor: IRCCS Burlo Garofolo

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

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-17
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo, syrup, one dose
domperidon	Domperidone	domperidone, syrup, 0,5 mg/Kg of body weight, one dose
ondansetron	Ondansetron	ondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose

Primary Outcome Measures

Name	Time	Method
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.	6 hours

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects needing hospital admission for the same illness;	48 hours
Percentage of subjects needing observation stay for more than 6 hours for the same illness	48 hours
Total emesis duration in the 3 allocation groups;	48 hours
Number of episodes of vomiting in the 3 treatment groups during the follow-up period	48 hours
Percentage of subjects presenting adverse events	48 hours

Trial Locations

Locations (15)

Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati; 🇮🇹 Avellino, Italy

Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili; 🇮🇹 Brescia, Italy

Dipartimento di Pediatria, Ospedale Castelli; 🇮🇹 Verbania, Novara, Italy

Dipartimento di Pediatria, Ospedale di Treviso; 🇮🇹 Treviso, Italy

Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer; 🇮🇹 Firenze, Italy

Unità Operativa di Pediatria, Ospedale GB Morgagni; 🇮🇹 Forlì, Italy

Divisione di Emergenza Pediatrica, Istituto G. Gaslini; 🇮🇹 Genova, Italy

Dipartimento di Pediatrica, Ospedale di Macerata; 🇮🇹 Macerata, Italy

Dipartimento di Pediatria, Azienda Policlinico di Modena; 🇮🇹 Modena, Italy

Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova; 🇮🇹 Padova, Italy

Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita; 🇮🇹 Torino, Italy

Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú; 🇮🇹 Roma, Italy

Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy

Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore; 🇮🇹 Verona, Italy

Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma; 🇮🇹 Parma, Italy