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Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02473887
Enrollment
40
Registered
2015-06-17
Start date
2014-09-30
Completion date
2015-01-31
Last updated
2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis

Keywords

ondansetron, palatability, vomiting

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.

Interventions

DRUGOndansetron with1:1 ORA - sweet.

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.

Sponsors

Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ondansetron serum level.4 hourserum level of ondansetron at 4 hours after drug administration.

Secondary

MeasureTime frameDescription
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 ).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026