Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
Sponsor study identifier
observational
462
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 26, 2011
Actual (reported)June 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2012
Actual (reported)June 2014
Actual (reported)June 26, 2014
Actual (reported)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
# episodes of vomiting after ondansetron administration
While in the ED, anticipated to be on average < 5 hours
Discharged home without IV
Duration of ED visit, anticipated to be on average < 5 hours
Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967
Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373
Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Graham Thompson, Physician
Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
David W Johnson, Physician
Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
462 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2011
First Posted
June 26, 2014
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2012
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
June 26, 2014
Record last verified: 2014-06
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