Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
Primary Purpose
Gastroenteritis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ondansetron with1:1 ORA - sweet.
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis focused on measuring ondansetron, palatability, vomiting
Eligibility Criteria
Inclusion Criteria:
- children 3-8 years of age.
- acute simple gastroenteritis with mild to moderate dehydration.
- more than 2 episodes of vomiting in 24 hours period.
Exclusion Criteria:
- known hypersensitivity to ondansetron.
- seizure disorder.
- chronic liver or kidney diseases.
- on any chronic medication.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastroenteritis with persistent vomiting.
Arm Description
patients with gastroenteritis with persistent vomiting received single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
Outcomes
Primary Outcome Measures
ondansetron serum level.
serum level of ondansetron at 4 hours after drug administration.
Secondary Outcome Measures
palatability score of the drug.score 3/5( not sure to like very much ).
Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. score 3/5( not sure to like very much ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02473887
Brief Title
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
Official Title
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to give children with gastroenteritis with persistent vomiting flavored intravenous ondansetron orally. The investigators test the palatability of the drug and check the serum level of ondansetron at 4 hours .
Detailed Description
This is a prospective pilot study for children,3-8 years of age presented to the Pediatric Emergency Department in the state of Qatar between September 2014 and January 2015, with acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in the last 24 hours, and who had failed oral rehydration trial in the department as per the department oral hydration protocol. Acute gastroenteritis was defined as diarrhea and vomiting for less than a week period.
Hydration level was assessed for all patients on arrival, and eligible patients were enrolled after obtaining an informed written consent.Enrolled patients received intravenous ondansetron form orally after being flavored 1:1 with ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight. Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. All patients were kept nil per oral for 30 minutes and then oral rehydration trial was started as per the department rehydration protocol. If the drug was vomited within 30 min of administration, a similar second dose was given. Blood level for ondansetron was collected 4 hours after the successful drug administration and was sent to the department laboratory within 5 min. Patients were sent home when they were ready for discharge as per the treating physician discretion. All patients were followed by a telephone call after 24 hours to assess the safety and efficacy of the orally taken ondansetron.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
ondansetron, palatability, vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gastroenteritis with persistent vomiting.
Arm Type
Experimental
Arm Description
patients with gastroenteritis with persistent vomiting received single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
Intervention Type
Drug
Intervention Name(s)
Ondansetron with1:1 ORA - sweet.
Other Intervention Name(s)
Zofran
Intervention Description
single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
Primary Outcome Measure Information:
Title
ondansetron serum level.
Description
serum level of ondansetron at 4 hours after drug administration.
Time Frame
4 hour
Secondary Outcome Measure Information:
Title
palatability score of the drug.score 3/5( not sure to like very much ).
Description
Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. score 3/5( not sure to like very much ).
Time Frame
within one minute from drug administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children 3-8 years of age.
acute simple gastroenteritis with mild to moderate dehydration.
more than 2 episodes of vomiting in 24 hours period.
Exclusion Criteria:
known hypersensitivity to ondansetron.
seizure disorder.
chronic liver or kidney diseases.
on any chronic medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Al-Ansari, MD, FRCPC, FAAP
Organizational Affiliation
Hamad Medical Corporation, Doha - Qatar
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16625009
Citation
Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
Results Reference
background
PubMed Identifier
18762604
Citation
DeCamp LR, Byerley JS, Doshi N, Steiner MJ. Use of antiemetic agents in acute gastroenteritis: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2008 Sep;162(9):858-65. doi: 10.1001/archpedi.162.9.858.
Results Reference
background
PubMed Identifier
22344213
Citation
Sturm JJ, Pierzchala A, Simon HK, Hirsh DA. Ondansetron use in the pediatric emergency room for diagnoses other than acute gastroenteritis. Pediatr Emerg Care. 2012 Mar;28(3):247-50. doi: 10.1097/PEC.0b013e3182494d87.
Results Reference
background
PubMed Identifier
10710025
Citation
Angelilli ML, Toscani M, Matsui DM, Rieder MJ. Palatability of oral antibiotics among children in an urban primary care center. Arch Pediatr Adolesc Med. 2000 Mar;154(3):267-70. doi: 10.1001/archpedi.154.3.267.
Results Reference
background
Learn more about this trial
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
We'll reach out to this number within 24 hrs