Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for th… (NCT04318847) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
220 participantsStarted 2021-10-10
Plain-language summary
This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.
The target population will be children between 4 and 13 years old who present vomiting.
Who can participate
Age range
4 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of at least 2 vomits in the last 4 hours.
* Negative tolerance test.
* Signature of the informed consent by the parents or legal guardians.
* Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
* Patients weighing 15 kg or more.
Exclusion Criteria:
* Altered conciousness.
* Sospected acute abdomen (appendicitis, invaginations...).
* Suspicion or presence of obstructive disease.
* Known severe digestive disease (Chron´s disease, ulcerative colitis...).
* Suspected food poisoning.
* Allergy to any of the drugs used in the study.
* Severe dehydration.
* Bilious vomiting.
* Previous abdominal surgery.
* Pathology that may affective degree of hydration of the patient (kidney failure, hypoalbuminemia..).
* Admission requirement or intravenous rehydration for any reason.
* Concomitant use of apomorphine.
* In relation to the possible lengthening of the QT, patients with problems of previous arrhythmia should be excluded or that they are receiving concomitant medication that can lengthen the QT, that have electrolyte disturbances.
* Patients receiving other serotonergic drugs.
* Patients who have undergone a previous adenotonsillectomy.
* Patients with hypocalcemia and/or hypomagnesemia.
* Patients with hereditary fructose intolerance.
* Diabetes patients.
* Lactose intolerant patients.
* Patients with indication of the low sodium diets.
* Hypersensitivity to ondansetron or other antagonists of the 5-HT3.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of children who return to medical/pediatric consultation for de same episode