|- candidate number||25249|
|- NTR Number||NTR5986|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2016|
|- Secondary IDs||NL59128 EudraCT 2016-003582-25|
|- Public Title||The effect of ondansetron on persisting vomitin in children with gastro-enteritis presenting at primary care out of hours service.|
|- Scientific Title||THE 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|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||General practice, Gastroenteritis, Children, Nausea , Cost-effectiveness |
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2016|
|- planned closingdate||1-jan-2018|
|- Target number of participants||220|
|- Interventions||Weight-based dose of oral ondansetron added to oral rehydration therapy.|
|- 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.|
|- Timepoints||Baseline (=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|
|- CONTACT FOR PUBLIC QUERIES||prof. dr. M.Y. Berger|
|- CONTACT for SCIENTIFIC QUERIES||prof. dr. M.Y. Berger|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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%
|- Main changes (audit trail)|
|- RECORD||1-sep-2016 - 16-sep-2016|