Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

• ClinicalTrials.gov Identifier: NCT02174874
• Recruitment Status: Completed
• First Posted: June 26, 2014
• Last Update Posted: June 26, 2014
• Sponsor: Dr. Graham Thompson
• Information provided by (Responsible Party): Dr. Graham Thompson, Alberta Children's Hospital

Study Description

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.

Condition or disease
Acute Gastroenteritis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 462 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
• Study Start Date: June 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: June 2014

Groups and Cohorts

Group/Cohort
Oral Ondansetron; Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967
Oral disintegrating tablets; Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373

Outcome Measures

Primary Outcome Measures :

1. proportion of patients who vomit within 15 minutes of administration of anti-emetic [ Time Frame: 15 minutes ]
   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.

Secondary Outcome Measures :

1. # episodes of vomiting after ondansetron administration [ Time Frame: While in the ED, anticipated to be on average < 5 hours ]
   To determine the number of episodes of vomiting while in the emergency department (after Ondansetron administration) that are experienced by the above population.
2. Discharged home without IV [ Time Frame: Duration of ED visit, anticipated to be on average < 5 hours ]
   To determine the proportions of children in each study group that are discharged home from the Emergency Department without receiving IV fluids.

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis

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.

Contacts and Locations

Locations

Canada, Alberta

Alberta Children's Hospital

Calgary, Alberta, Canada, T3B 6A8

Sponsors and Collaborators

Dr. Graham Thompson

Investigators

• Principal Investigator: Graham Thompson, Physician; Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
• Principal Investigator: David W Johnson, Physician; Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary

More Information

• Responsible Party: Dr. Graham Thompson, Physician, Alberta Children's Hospital
• ClinicalTrials.gov Identifier: NCT02174874
• Other Study ID Numbers: OND - 0001
• First Posted: June 26, 2014
• Last Update Posted: June 26, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases