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

NCT04318847 | Unknown Phase 4

• 1 other identifier: OND-URG
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ondransetron

EXPERIMENTAL

Administration of ondansetron

Drug: Ondansetron 4 MG

Habitual Clinical Practice

NO INTERVENTION

Habitual Clinical Practice

Interventions

Ondansetron 4 MG DRUG

Administration of ondansetron 4 mg or 8 mg according to weight

Ondransetron

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lizar Aguirre Pascasio: lead

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Lizar Aguirre Pascasio, Dr

CONTACT

945007374; LIZAR.AGUIRREPASCASIO@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor in Medicine

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: October 10, 2021
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: April 21, 2021

Record last verified: 2021-04