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The effect of ondansetron on persisting vomitin in children with gastro-enteritis presenting at primary care out of hours service.


- candidate number25249
- NTR NumberNTR5986
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2016
- Secondary IDsNL59128 EudraCT 2016-003582-25
- Public TitleThe effect of ondansetron on persisting vomitin in children with gastro-enteritis presenting at primary care out of hours service.
- Scientific TitleTHE ADDED EFFECT OF ORAL ONDANSETRON TO CARE-AS-USUAL ON PERSISTING VOMITING IN CHILDREN AGED 6 MONTHS TO 6 YEARS, PRESENTING AT PRIMARY CARE OUT OF HOURS SERVICE WITH ACUTE GASTRO-ENTERITIS AND CONCOMITANT VOMITING
- ACRONYMKOOKING
- hypothesisOral 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.
- Healt Condition(s) or Problem(s) studiedGeneral practice, Gastroenteritis, Children, Nausea , Cost-effectiveness
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate1-jan-2018
- Target number of participants220
- InterventionsWeight-based dose of oral ondansetron added to oral rehydration therapy.
- Primary outcomeThe proportion of children that continue to vomit within the first 4 hours after presentation at the OHS with acute gastro-enteritis.
- Secondary outcomeCessation 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.
- 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
- statusplanned
- CONTACT FOR PUBLIC QUERIESprof. dr. M.Y. Berger
- CONTACT for SCIENTIFIC QUERIESprof. dr. M.Y. Berger
- 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, 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%
- Main changes (audit trail)
- RECORD1-sep-2016 - 16-sep-2016


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