Palatability of Oral Rehydration Solutions

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Gastroenteritis

Treatments

Drug: Enfalyte

Drug: Pedialyte

Drug: Pediatric Electrolyte

Study type

Interventional

Funder types

Other

Identifiers

NCT00689312

1000012122

Details and patient eligibility

About

The primary objective of this study is to compare the mean taste scores for three fruit flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective is to compare the proportions of children who indicate a taste preference for one of the solutions.

Full description

In Canada, acute gastroenteritis remains a major cause of morbidity and hospitalizations. This, in large part, is due to an inability to realize the full benefits of oral rehydration therapy. Because oral rehydration solutions have a salty taste, many mild to moderate dehydrated children refuse to drink them. This has resulted in pediatricians recommending inappropriate solutions and the unnecessary administration of intravenous fluids. Although two meta-analyses have concluded that rice-based ORS (Enfalyte) is as or more effective than traditional ORS in reducing stool output, the palatability of different oral rehydration solutions have never been evaluated.

This will be the first prospective trial comparing the palatability of the most commonly recommended oral rehydration solutions, Pedialyte and Enfalyte with a newer solution, Pediatric Electrolyte. Both Pedialyte and Pediatric Electrolyte contain sucralose, dextrose, and fructose while Enfalyte contains rice syrup solids. Although the latter is as, or more effective than Pedialyte in reducing stool output, palatability may limit its use. Taste is important as children with gastroenteritis are frequently nauseated and may refuse to drink or vomit when consuming less palatable solutions.

We hypothesize that, compared to children who receive a rice-based ORS (Enfalyte), those who receive a sucralose ORS (Pediatric Electrolyte or Pedialyte) will report a higher mean taste score, will prefer to drink the sucralose sweetened ORS if they had to consume a larger volume, and are more likely to drink the entire volume they are provided.

Enrollment

66 patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department

Exclusion criteria

Children with diarrhea, a vomiting or diarrhea episode within 24 hours, head trauma, abdominal pain, upper respiratory symptoms, or nil per os status
Patients with gastrointestinal symptoms