Gastroenteritis
Conditions
Interventions
Trade Name: Ondansetron
Product Name: Ondansetron
Product Code: RVG 31839
Pharmaceutical Form: Coated tablet
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/ At least > 24 hours, episodes of nonbilious, nonbloody vomiting with at least one reported episode of vomiting within the four hours preceding presentation; 2/ At least one episode of diarrhea during the period of illness; 3/ At risk for dehydration OR mild to moderate dehydration, both as defined by the Dutch College of General Practitioners; 4/ Parental written informed consent 5/ Aged 6 months to 6 years Are the trial subjects under 18? yes Number of subjects for this age range: 1064 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1/ Severe dehydration requiring direct referral (comatose mental status; bradycardia; weak, thready or impalpable pulses; very low skin pinch (>2 seconds); prolonged or minimal capillary refill; cold, mottled or cyanotic extremities; minimal (to no) urine output; circulatory collaps); 2/ Use of anti-emetics in the previous 6 hours; 3/underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia); 4/ chronic disease increasing risk of a complicated course (such as diabetes or IBD.); 5/ history of abdominal surgery; 6/ known sensitivity to 5-HT3 receptor antagonists; 7/ known prolonged QT-interval or cardiac dysrhythmia; 8/ QT prolonging medication; 9/ previous enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare the effects and cost-effectiveness of oral ondansetron plus oral rehydration therapy (ORT) with ORT alone in children aged between 6 months and 6 years attending out of hours services with acute gastroenteritis and vomiting.;Secondary Objective: Moreover, we intend to evaluate the predictive value of patient characteristics and symptoms for the risk of dehydration in a population of children at risk for dehydration.;Primary end point(s): The number of referrals to a (pediatric) emergency department over a period of 5 days.;Timepoint(s) of evaluation of this end point: We will evaluate the primary end point when the study ends (estimated in 2017). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cessation of vomiting, the number of vomiting episodes during ORT, the proportion that required intravenous rehydration, the proportion hospitalization, quality of life and healthcare use and costs.;Timepoint(s) of evaluation of this end point: We will evaluate the secondary end points when the study ends (estimated in 2017). | — |
Countries
Netherlands
Contacts
Public ContactDepartment of General Practice
University Medical Center Groningen
Outcome results
None listed