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

NCT ID: NCT04318847

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2023-04-10

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.

Conditions

Vomiting in Infants and/or Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ondransetron

Administration of ondansetron

Group Type: EXPERIMENTAL

Ondansetron 4 MG

Intervention Type: DRUG

Administration of ondansetron 4 mg or 8 mg according to weight

Habitual Clinical Practice

Habitual Clinical Practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ondansetron 4 MG

Administration of ondansetron 4 mg or 8 mg according to weight

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lizar Aguirre Pascasio

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lizar Aguirre Pascasio

Doctor in Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Lizar Aguirre Pascasio, Dr

Role: CONTACT

LIZAR.AGUIRREPASCASIO@osakidetza.eus

945007374

Other Identifiers

OND-URG

Identifier Type: -

Identifier Source: org_study_id