Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)

Gastroenteritis leading to dehydration is very commonly encountered in the pediatric
emergency room setting. Oral rehydration therapy (ORT) is the first line therapy recommended
by the American Academy of Pediatrics but is seldom used compared to intravenous therapy
(IVT). ORT has many advantages including less traumatic to the patient, can be administered
by mouth, can be administered at home and less costly compared to IVT. Furthermore,
intravenous fluids may present several complications with IV placement such as infiltration,
hematoma, air embolism, phlebitis, extravascular injection, intraarterial injection, etc.
Speedlyte is a new oral rehydration product with lipophilic absorption which allows for
electrolytes to be more readily absorbed compared to other oral rehydration solutions. The
liposome encapsulates the salty molecules which is thought to decrease the negative salty
taste associated with oral rehydration solutions. In addition, the encapsulation of
electrolytes allows for more molecules to be delivered past the stomach acids and absorbed
into the body under higher bioavailability due to the lipid shell.

Participants will be randomized into two rehydration groups. One group will receive oral
rehydration with the Speedlyte product, the amount will be based on the participant's weight.
The other group will receive intravenous rehydration with a normal saline bolus per physician
practice, usually in the amount of 20 mL/kg. These interventions can be incorporated into the
emergency room practice without undue expense to the setting or placing excessive demands on
nursing time as these practices are standard of care in many rehydration cases.

Inclusion Criteria:

- 6 mths to 18 years;

- Signs and symptoms of dehydration for less than a week

- Diagnosis of acute gastroenteritis, dehydration, vomiting, and/or diarrhea;

- Patient able to drink from bottle and/or cup;

- Per clinician's judgment, patient needs rehydration with IV solution.

Exclusion Criteria:

- Chronic disease that includes but not limited to TB, HIV, congenital heart disease
with hemodynamic consequences, metabolic disease, cerebral palsy, adrenal hyperplasia,
renal tubular acidosis, and nephropathy;

- Vomiting due to head trauma;

- Severe hydration;

- Diabetic ketoacidosis;

- Bloody diarrhea;

- Diarrhea for more than a week;

- Malnutrition;

- Burns;

- Pneumonia;

- Meningitis;

- History of seizures;

- Absent bowel sounds;

- Not able to drink from bottle or cup;

- Previous allergic reaction to citrate or other food coloring particles/formulation;

- Parent/legal guardian refusing to participate.