Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00691275
Study type	Interventional
Source	Children's Hospitals and Clinics of Minnesota
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2008
Completion date	September 2009

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04079543` - NPO and Patient Satisfaction in the Cath Lab	N/A
Recruiting	`NCT06063655` - Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults	N/A
Completed	`NCT05111392` - Hydration Dynamics and Influence of Beverage Composition	Phase 1/Phase 2
Terminated	`NCT02486224` - Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance	N/A
Recruiting	`NCT02249845` - Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children	N/A
Completed	`NCT01285713` - IV Glucose for Dehydration Treatment	Phase 2
Completed	`NCT00360204` - Improving Health Outcomes for New Mothers and Babies	Phase 3
Completed	`NCT00370968` - Zinc-ORS in Severe and Complicated Acute Diarrhea	Phase 2/Phase 3
Completed	`NCT04076995` - INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers	N/A
Recruiting	`NCT05768789` - Buoy Electrolyte Study on Hydration Status of Active Men and Women	N/A
Not yet recruiting	`NCT05943366` - Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults	N/A
Not yet recruiting	`NCT05428228` - Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults	N/A
Completed	`NCT04997031` - Tap Water Intake and Perceptions in US Latinx Adults
Completed	`NCT04536324` - The Absorption Rate of Subcutaneous Infused Fluid
Completed	`NCT02926989` - Intravenous Fluids in Hospitalised Children	Phase 4
Completed	`NCT04874584` - Culturally Tailored Nurse Coaching Study for Cancer Symptom Management	N/A
Completed	`NCT02265575` - Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration	Phase 2
Completed	`NCT02206581` - Using Hydration Monitor to Detect Changes in the Hydration Status Athletes	N/A
Completed	`NCT01893853` - Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)	N/A
Completed	`NCT01503996` - Drinking Habits of Glaucoma Patients and Age Matched Controls	N/A