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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vomiting in Infants and/or Children
• Intervention / Treatment: Drug: Ondansetron 4 MG

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lizar Aguirre Pascasio, Dr; Phone Number: 945007374; Email: LIZAR.AGUIRREPASCASIO@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ondransetron; Administration of ondansetron	Drug: Ondansetron 4 MG; Administration of ondansetron 4 mg or 8 mg according to weight
NO_INTERVENTION: Habitual Clinical Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lizar Aguirre Pascasio

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 10, 2021
• Primary Completion (ANTICIPATED): April 10, 2023
• Study Completion (ANTICIPATED): April 10, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Signs and Symptoms, Digestive; Water-Electrolyte Imbalance; Vomiting; Dehydration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: OND-URG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No