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van CCT (UK)

van CCT (UK)

The effect of ondansetron on referral rate in children with gastro-enteritis and vomiting.

- candidate number20886
- NTR NumberNTR4906
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2014
- Secondary IDsNL50760 EudraCT number 2014-004621-40
- Public TitleThe effect of ondansetron on referral rate in children with gastro-enteritis and vomiting.
- Scientific TitleThe effect of oral ondansetron on referral rate in children aged 6 months to 6 years attending in primary care out of hours service with acute gastro-enteritis and vomiting.
- hypothesisOral ondansetron reduces the proportion of referred children to a (paediatric) emergency department when added to oral rehydration therapy compared to oral rehydration therapy alone.
- Healt Condition(s) or Problem(s) studiedGeneral practice, Children, Gastroenteritis, Cost-effectiveness , Nausea
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-okt-2015
- planned closingdate1-jan-2018
- Target number of participants1064
- InterventionsWeight-based dose of oral ondansetron added to oral rehydration therapy.
- Primary outcomeThe proportion of referrals to a (paediatric) emergency department over a period of 5 days.
- Secondary outcomeCessation 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.
- TimepointsBaseline (=T0), every hour after baseline for the first four hours (=T1 - T4) for the first day. Second day until the seventh (=T5-T11)
- Trial web site
- statusstopped
- CONTACT for SCIENTIFIC QUERIESDr. Y. Lisman-van Leeuwen
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryOBJECTIVE: 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
- Main changes (audit trail)16-sept-2016: Study amendment change primary outcome METC approved. New NTR number 5986.
- RECORD6-nov-2014 - 16-sep-2016

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