Background: Acute viral gastroenteritis is a very common pediatric medical condition that
results in a large number of emergency department (ED) visits. Fasting-induced ketosis
has been suggested to contribute to nausea and vomiting in children with VGE. To date,
there is no data on the impact of oral sucrose intake during oral rehydration.
Objective: The aim of this study is to assess the impact of providing a sucrose solution
at triage to young children with suspected acute viral gastroenteritis on the amount of
rehydration solution intake in the first 2 hours. We will also assess the proportion of
discharge after initial medical evaluation, the proportion of oral rehydration failure,
the number of vomiting episodes per patient, ondansetron administration, the time between
the intervention and ED discharge, the time between the first medical contact and ED
discharge and return visits within 48 hours.
Methods:
This study will be a double-blind randomized controlled trial. Recruitment will take
place in a tertiary pediatric ED. Participants will be all children who present to the ED
with suspected acute acute viral gastroenteritis with at least three vomiting in the
previous 24 hours. The intervention will consist in giving 1.5 ml/kg of a sucrose
solution composed of diluted juice with added table sugar (3.5g of sucrose/10 ml)
compared with 1.5 ml/kg of diluted juice (0.5g of sucrose/10 mL, standard of care in our
ED). Following that, all participants will be rehydrated with 15 mL of diluted juice
every 15 minutes or more if tolerated. The primary outcome will be the amount of
rehydration solution (ml) absorbed in the first two hours following intervention.
Secondary outcomes will include disposition after initial medical evaluation, oral
rehydration failure, the number of vomiting, ondansetron administration, the time between
the intervention and ED discharge, the time between the first medical contact and ED
discharge and return visits within 48 hours. The primary analysis will be the difference
in the amount of tolerated oral rehydration between the two groups. Based on a
preliminary study of children suffering from VGE, it was estimated that the recruitment
of 238 participants would provide a power of 80% to identify a difference of 15 ml
between the two groups.
Expected results:
We hope that this study will demonstrate that an oral sucrose solution given at triage to
children presenting with symptoms compatible with acute acute viral gastroenteritis
promotes oral hydration and consequently increases the total amount of rehydration
solution tolerated by children.