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

Vomiting in Infants and/or Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318847
• Other study ID #: OND-URG
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 10, 2021
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2021
• Source: Basque Health Service
• Contact: Lizar Aguirre Pascasio, Dr
• Phone: 945007374
• Email: LIZAR.AGUIRREPASCASIO[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Vomiting
• Vomiting in Infants and/or Children

Intervention

Drug:
• Ondansetron 4 MG
Administration of ondansetron 4 mg or 8 mg according to weight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lizar Aguirre Pascasio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children who return to medical/pediatric consultation for de same episode	Is calculated percentage of children who return to medical/pediatric consultation for de same episode of vomiting	An average of 24 months