Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

NCT ID: NCT02174874

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 462 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Acute Gastroenteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oral Ondansetron

Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967

No interventions assigned to this group

Oral disintegrating tablets

Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373

No interventions assigned to this group

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Graham Thompson

OTHER

Sponsor Role: lead

Responsible Party

Dr. Graham Thompson

Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Graham Thompson, Physician

Role: PRINCIPAL_INVESTIGATOR

Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary

David W Johnson, Physician

Role: PRINCIPAL_INVESTIGATOR

Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

OND - 0001

Identifier Type: -

Identifier Source: org_study_id