Vomiting in Infants and/or Children
Conditions
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 and 13 years old who present vomiting.
Interventions
DRUGOndansetron 4 MG
Administration of ondansetron 4 mg or 8 mg according to weight
Sponsors
Lizar Aguirre Pascasio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of children who return to medical/pediatric consultation for de same episode | An average of 24 months | Is calculated percentage of children who return to medical/pediatric consultation for de same episode of vomiting |
Contacts
Primary ContactLizar Aguirre Pascasio, Dr
Outcome results
None listed