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.
ID
Bron
Verkorte titel
Aandoening
General practice, Paediatrics, Acute gastroenteritis, Child, Cost-effectiveness, Antiemetic
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The proportion of referrals to a (paediatric) emergency department over a period of 5 days.
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
Baseline (=T0), every hour after baseline for the first four hours (=T1 - T4) for the first day. Second day until the seventh (=T5-T11)
Onderzoeksproduct en/of interventie
Weight-based dose of oral ondansetron added to oral rehydration therapy.
Algemeen / deelnemers
Y. Lisman-van Leeuwen
Groningen
The Netherlands
050-3637525
y.lisman-van.leeuwen@umcg.nl
Wetenschappers
Y. Lisman-van Leeuwen
Groningen
The Netherlands
050-3637525
y.lisman-van.leeuwen@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4700 |
NTR-old | NTR4906 |
CCMO | NL50760.042.15 |
OMON | NL-OMON41825 |