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Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174874
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Graham Thompson, Alberta Children's Hospital

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.

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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

Resource links provided by the National Library of Medicine


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



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174874


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
Dr. Graham Thompson
Investigators
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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
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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    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases