Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)
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ClinicalTrials.gov Identifier: NCT02174874 |
Recruitment Status :
Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
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Condition or disease |
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Acute Gastroenteritis |
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 |

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

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
Canada, Alberta | |
Alberta Children's Hospital | |
Calgary, Alberta, Canada, T3B 6A8 |
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 |
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 |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |