Clinical trial NCT02174874: Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)
Official title: Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Gastroenteritis
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 462
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis

Brief summary: In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.

Detailed description: Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.

Eligibility criteria: Inclusion Criteria:

* Children aged 3 months to 10 years with recent,
* significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
* The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.

Exclusion Criteria:

* Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
* These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.

Primary outcomes:
measure: proportion of patients who vomit within 15 minutes of administration of anti-emetic
timeFrame: 15 minutes
Secondary outcomes:
measure: # episodes of vomiting after ondansetron administration
timeFrame: While in the ED, anticipated to be on average < 5 hours
measure: Discharged home without IV
timeFrame: Duration of ED visit, anticipated to be on average < 5 hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
name: Graham Thompson, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
name: David W Johnson, Physician
role: PRINCIPAL_INVESTIGATOR
References: