The added effect of oral ondansetron to care-as-usual on persisting<br>vomiting in children aged 6 months to 6 years, presenting at primary care<br>out of hours service with acute gastro-enteritis and concomitant vomiting

Completed

• Conditions: gastroenteritis; stomach flu; 10017947; 10047438

• Registration Number: NL-OMON43048
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

1. Aged 6 months to 6 years;
2. At least four reported episodes of vomiting or diarrhoea during the
last twenty-four hours preceding presentation
3. At least one reported episode of vomiting within the four hours
preceding presentation;
4. Diagnosed with AGE by a general practitioner at the OHS.
5. Parental written informed consent.

Exclusion Criteria

1. Use of anti-emetics in the previous 6 hours;
2. Known renal failure or hypoalbuminemia (as this could affect the
assessment of hydration status);
3. Known diabetes mellitus or inflammatory bowel disease (as this
could increase the risk of a complicated course);
4. A history of abdominal surgery, with suspected recurrence of original
abdominal symptoms or strangulation ileus explaining current
symptoms, according to the general practitioner.
5. Known sensitivity to 5-HT3 receptor antagonists;
6. Known prolonged QT interval;
7. Current use of QT prolonging medication;
8. Previous enrolment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint constitutes the proportion of children that continue to<br /><br>vomit within the first 4 hours after presentation at the OHS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. What are the costs of ondansetron and CAU compared to CAU in children<br /><br>presenting at OHS who are diagnosed by a GP as AGE?<br /><br>2. What is the cost-effectiveness of ondansetron and CAU compared to just CAU?<br /><br>3. What is the added effect of ondansetron to CAU on the proportion of children<br /><br>referred to a (pediatric) emergency department in children presenting at OHS<br /><br>with acute gastro-enteritis?</p><br>