Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Phase 1

Completed

• Conditions: Gastroenteritis

• Registration Number: NCT02473887
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-06-14
• Last Update Submitted: 2015-06-14
• Study First Posted: 2015-06-17
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ondansetron serum level.	4 hour	serum level of ondansetron at 4 hours after drug administration.

Secondary Outcome Measures

Name	Time	Method
palatability score of the drug.score 3/5( not sure to like very much ).	within one minute from drug administration.	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 ).