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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| # 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 |
| Discharged home without IV |
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Inclusion Criteria:
Exclusion Criteria:
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Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
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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 |