Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

Acute Gastroenteritis Clinical Trial

Official title:

Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174874
• Other study ID #: OND - 0001
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: June 24, 2014
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Alberta Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: June 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 10 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Graham Thompson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients who vomit within 15 minutes of administration of anti-emetic	To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.	15 minutes	No
Secondary	# episodes of vomiting after ondansetron administration	To determine the number of episodes of vomiting while in the emergency department (after Ondansetron administration) that are experienced by the above population.	While in the ED, anticipated to be on average < 5 hours	No
Secondary	Discharged home without IV	To determine the proportions of children in each study group that are discharged home from the Emergency Department without receiving IV fluids.	Duration of ED visit, anticipated to be on average < 5 hours	No