Clinical trial NCT05378776: Sucrose at Triage for Acute Gastroenteritis Episode in Children
Official title: Triage Administration of Sucrose for Gastroenteritis in Children; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis Acute
Vomiting
Keywords: children
sucrose
emergency department
triage
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 6 years. We will restrict to this age group to have a more homogenous group.
* At least 3 non-bilious, non-bloody, vomiting in the last 24 hours
* No other diagnostic more likely than acute viral gastroenteritis suspected at triage

Exclusion Criteria:

* Severe dehydration (based on poor capillary refill or hypotension)
* Hypoglycemia identified by the triage nurse (\< 2,8 mmol)
* Bilious or bloody vomiting
* Chronic disease other than asthma
* Previous inclusion in the study
* Inability to obtain parental informed consent (language barrier, absence, etc.)

Primary outcomes:
measure: Mean amount of tolerated oral rehydration in mL
timeFrame: 2 hours after intervention
Secondary outcomes:
measure: Number of participants who needed an observation
timeFrame: 2 hours
measure: Number of participants with oral rehydration failure
timeFrame: 6 hours
measure: Mean number of vomiting
timeFrame: 6 hours
measure: Number of participants who received ondansetron
timeFrame: 6 hours
measure: Mean length of stay
timeFrame: 24 hours
measure: Mean length of stay after physician evaluation
timeFrame: 24 hours
measure: Number of participants who had a return visit
timeFrame: 48 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
Study officials:
References: