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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||462 participants|
|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|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174874
|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|