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ID
Source
Brief title
Health condition
Huisartsgeneeskunde (General Practice), Kinderen (Children), Gastro-enteritis (gastroenteritis), Kosteneffectiviteit (cost-effectiveness), Misselijkheid (vomiting)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of children that continue to vomit within the first 4 hours after presentation at the OHS with acute gastro-enteritis.
Secondary outcome
Cessation of vomiting, the number of vomiting episodes during ORT, referral to a (pediatric) emergency department), intravenous rehydration, hospital admission rate and duration, 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
OBJECTIVE: To evaluate cost-effectiveness of ondansetron in children with acute gastro-enteritis (AGE ) and vomiting at a general practitioner cooperative out-of-hours service (OHS)
RESEARCH QUESTION: What is the cost-effectiveness of ondansetron and oral rehydration therapy (ORT) compared to ORT alone?
HYPOTHESIS: With an effective one-intake-treatment that stops vomiting and consequently facilitates ORT, persisting vomiting and referral rate will be reduced and consequently will reduce costs
STUDY DESIGN: Pragmatic Randomized Controlled Trial
STUDY POPULATION: Vomiting children aged 6 months to 6 years with AGE attending OHS
INTERVENTION: Oral ondansetron added to ORT
SAMPLE SIZE We have to include 220 children in order to observe a significant reduction in persisting vomiting from an expected 35% to 15%
Study objective
Oral ondansetron reduces the proportion of children that continue to vomit within the first 4 hours after presentation at the OHS when added to oral rehydration therapy compared to oral rehydration therapy alone.
Study design
Baseline (=T0), every hour after baseline for the first four hours (=T1 - T4) for the first day. Second day until the seventh (=T5-T11)
Intervention
Weight-based dose of oral ondansetron added to oral rehydration therapy.
M.Y. Berger
Postbus 196
Groningen 9700 AD
The Netherlands
Email: m.y.berger@umcg.nl
M.Y. Berger
Postbus 196
Groningen 9700 AD
The Netherlands
Email: m.y.berger@umcg.nl
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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5830 |
| NTR-old | NTR5986 |
| CCMO | NL59128.042.16 |
| OMON | NL-OMON43048 |