The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…
ID
Source
Brief title
Condition
- Gastrointestinal disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint constitutes the proportion of children that continue to
vomit within the first 4 hours after presentation at the OHS.
Secondary outcome
1. What are the costs of ondansetron and CAU compared to CAU in children
presenting at OHS who are diagnosed by a GP as AGE?
2. What is the cost-effectiveness of ondansetron and CAU compared to just CAU?
3. What is the added effect of ondansetron to CAU on the proportion of children
referred to a (pediatric) emergency department in children presenting at OHS
with acute gastro-enteritis?
Background summary
Acute gastroenteritis (AGE) is a common childhood infectious disease, affecting
almost all children younger than 5 years at least once. AGE is usually
uncomplicated and self-limiting, however, it can lead to severe dehydration.
The risk for dehydration is highest if in addition to diarrhea also vomiting is
present, which is a distressing symptom for both children and their caregivers.
AGE is a very common reason for children to consult a general practitioner.
Approximately 5% of consultations of children under five years old concern AGE.
This percentage is similar for consultations during regular general practice
hours and "evening, night and weekend" hours, delivered at general
practitioners cooperative out-of-hours services (OHS). Management of AGE
depends on the severity of symptoms and the risk for dehydration. Recently,
ondansetron, an antiemetic prescribed for vomiting caused by chemotherapy, was
found to be effective in reducing hospital admissions in children with AGE. In
the United States the use of ondansetron at paediatric emergency departments
increased dramatically since then. Serious adverse events of orally
administered ondansetron are not reported thus far. Herewith, oral ondanetron
for young children with AGE and vomiting might be a potentially effective and a
safe strategy to stop vomiting and facilitate the use of ORT thereby reducing
referral rates and costs in primary care OHS.
Study objective
The primary objective is to determine the added effect of oral ondansetron to
care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4
hours after presentation at an out-of-hours primary care service (OHS) in
children aged 6 months to 6 years with acute gastroenteritis.
Study design
pragmatic randomized controlled trial with a total follow-up of 7 days after
randomization. There are two treatment groups. Group A will receive care as
usual and group B will receive ondansetron in addition to care as usual.
Intervention
Single weight-based dose of oral ondansetron.
Study burden and risks
All participants will be assessed by a general practitioner and receive care as
usual (including ORT). A parent kept diary with baseline measures and
health-related questions is completed daily. This diary will be collected at
home by a research assistant. In a random selection of enrolled children body
weight will be measured on a daily basis. The intervention group receives care
as usual and a single dose of oral ondansetron administered by the research
assistant. Serious adverse events of orally administered ondansetron are not
reported thus far. Therefore it might be an effective and safe strategy to stop
vomiting and to facilitate ORT, thereby reducing referral rates and costs in
primary care.
Antonius Deusinglaan HPC:FA21 1
Groningen 9713 AV
NL
Antonius Deusinglaan HPC:FA21 1
Groningen 9713 AV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003582-25-NL |
| CCMO | NL59128.042.16 |
| OMON | NL-OMON26937 |