The primary objective is to study the effect of oral Ondansetron and oral rehydration therapy on the number of referrals to a pediatric emergency department in children aged 6 months to 6 years attending an out-of-hours primary care service (OHS)…
ID
Source
Brief title
Condition
- Gastrointestinal disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the number of referrals to a (pediatric) emergency
department over a period of 7 days.
Secondary outcome
Secundary study parameters are: cessation of vomiting, the number of vomiting
and diarrhea episodes during ORT, intravenous rehydration, hospitalization,
quality of life, healthcare use and costs. A vomiting episode will be recorded
by the parent when a forceful expulsion of stomach contents occurs. Episodes
separated by no more than two minutes will be counted as a single episode.
Nonproductive retching, spilling of oral contents, and drooling are not
considered vomiting. Cessation of vomiting will be noted at the time of a
vomiting episode after which no more than 1 vomiting episode is noted during a
period of at least 1 day.
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 ondansetron
for young children with AGE and vomiting might be a potentially effective and a
safe strategy to reduces referral rates and costs in primary care. It's
cost-effectiveness in this setting, however, has never been demonstrated.
Study objective
The primary objective is to study the effect of oral Ondansetron and oral
rehydration therapy on the number of referrals to a pediatric emergency
department in children aged 6 months to 6 years attending an out-of-hours
primary care service (OHS) with gastroenteritis in comparison to oral
rehydration therapy alone.
Study design
A pragmatic randomised controlled trial with a total follow-up of 7 days after
randomisation. There are two treatment groups. Group A receives ORT alone and
group B will receive ORT and oral ondansetron.
Intervention
The intervention group receives oral ondansetron and ORT (both based on
weight).
Study burden and risks
All participants will be assessed by a general practitioner and receive ORT
(standard care). A parent kept diary with baseline measures, the EQ-D-Y
questionnaire 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 standard care and a single dose oral Ondansetron administered by the
research assistant. Serious adverse events of orally administered Ondansetron
are not reported thus far. Herewith, it reduced vomiting in children and
therefore might be an effective and safe strategy to improve well-being and
reduce referral rates and costs in primary care.
A. Deusinglaan 1
Groningen 9713 AV
NL
A. Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
1. Aged 6 months to 6 years;
2. At least > 24 hours with episodes of nonbilious, nonbloody vomiting;
3. At least one reported episode of vomiting within the four hours preceding presentation;
4. At least one episode of diarrhea during the period of illness;
5. Parental written informed consent.
Exclusion criteria
1/ Requiring direct referral as deemed by the GP
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
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 | EUCTR2014-004621-40-NL |
| CCMO | NL50760.042.15 |
| OMON | NL-OMON21316 |