Status:
UNKNOWN
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
Lead Sponsor:
Lizar Aguirre Pascasio
Conditions:
Vomiting in Infants and/or Children
Eligibility:
All Genders
4-13 years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2023
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04318847
Start Date
October 10 2021
End Date
April 10 2023
Last Update
April 21 2021
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