Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120744
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2005-07-12
Brief Title:
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of the study were to determine whether ondansetron treatment would reduce
the amount of vomiting in the emergency department
the need for intravenous rehydration and
the need for hospitalization
the amount of vomiting in the emergency department
the need for intravenous rehydration and
the need for hospitalization
Detailed Description:
Background
Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis emergency department revisits may increase
Methods
The investigators conducted a prospective double-blind randomized trial at a pediatric emergency department in 214 dehydrated children aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo Oral rehydration was administered according to a standard protocol The primary outcome was the proportion of children who vomited during oral rehydration therapy The secondary outcomes were the mean number of episodes of vomiting and the proportion of children treated with intravenous rehydration or hospitalized
Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis emergency department revisits may increase
Methods
The investigators conducted a prospective double-blind randomized trial at a pediatric emergency department in 214 dehydrated children aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo Oral rehydration was administered according to a standard protocol The primary outcome was the proportion of children who vomited during oral rehydration therapy The secondary outcomes were the mean number of episodes of vomiting and the proportion of children treated with intravenous rehydration or hospitalized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None