Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.

Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial \[1-4\]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients \[5\]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.

The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.

Hypothesis:

Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department

NCT00120744

Gastroenteritis Vomiting Diarrhea +1 more

COMPLETED NA

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

Vomiting in Infants and/or Children

UNKNOWN PHASE4

Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

NCT02174874

Acute Gastroenteritis

COMPLETED

Symptomatic Treatment of Acute Gastroenteritis

NCT01257672

Gastroenteritis Vomiting Acute Gastroenteritis

COMPLETED PHASE3

Antiemetic Efficacy of Ondansetron Versus Metoclopramide

NCT02619201

Acute Gastroenteritis Vomiting

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dehydration Gastroenteritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1

Zofran

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ondansetron

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 6 months - 5 years
* Clinical diagnosis of acute gastroenteritis
* Mild or moderate dehydration as determined by validated clinical scale
* Clinical assessment to begin IV fluids
* Vomiting ≥ 2 episodes in past 4 hours

Exclusion Criteria

* Severe dehydration
* History of significant gastrointestinal, metabolic, renal or cardiac disorder
* Ondansetron allergy
* Non-English language proficient parent/guardian
* Parent/guardian has no telephone

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No