No registrations found.
ID
Source
Brief title
Health condition
General practice, Paediatrics, Acute gastroenteritis, Child, Cost-effectiveness, Antiemetic
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of referrals to a (paediatric) emergency department over a period of 5 days.
Secondary outcome
Cessation of vomiting, the number of vomiting episodes during ORT, 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, 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
PRIMARY CLINICAL OUTCOME IN COST EFFECTIVENESS ANALYSIS: the number of referrals to a
paediatric emergency department prevented
SAMPLE SIZE We have to include 824 children in order to observe a significant reduction in referral rate from an expected 9% to 4.5%
ANTICIPATED HEALTHCARE EFFICIENCY GAIN: This intervention may prevent over 2000 hospital
admissions annually in the Netherlands
Study objective
Oral ondansetron reduces the proportion of referred children to a (paediatric) emergency department 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.
Y. Lisman-van Leeuwen
Groningen
The Netherlands
050-3637525
y.lisman-van.leeuwen@umcg.nl
Y. Lisman-van Leeuwen
Groningen
The Netherlands
050-3637525
y.lisman-van.leeuwen@umcg.nl
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 to an emergency department according to GP;
2. Use of anti-emetics in the previous 6 hours;
3. Known renal failure or hypoalbuminemia (as this could affect the assessment of hydration status);
4. Known diabetes mellitus or inflammatory bowel disease (as this could increse the risk of a complicated course);
5. A history of abdominal surgery;
6. Known sensitivity to 5-HT3 receptor antagonists;
7. Known prolonged QT-interval;
8. Current use of QT-prolonging medication;
9. 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 | NL4700 |
| NTR-old | NTR4906 |
| CCMO | NL50760.042.15 |
| OMON | NL-OMON41825 |