Effect of oral Ondansetron on Decreasing the Vomiting Associated With Acute Gastroenteritis in pediatrics

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138710221545N1

Enrollment

176

Registered

2011-02-26

Start date

2010-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Acute gastroenteritis. Diarrhoea and gastroenteritis of presumed infectious origin

Interventions

Intervention 1: Ondansetron tablets, 30 minutes before ORT, with dosage adjusting based on patient`s weight ( Using ondansetron 4 mg tablets ). Intervention 2: Placebo tablets, 30 minutes before ORT.

Treatment - Drugs

Placebo

Ondansetron tablets, 30 minutes before ORT, with dosage adjusting based on patient`s weight ( Using ondansetron 4 mg tablets )

Placebo tablets, 30 minutes before ORT

Eligibility

Sex/Gender

All

Age

1 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 1 to 10 years old, Simple acute gastroenteritis, mild to moderate dehydration, Onset of disease in 24 hours prior to the study, At least one episode of vomiting in 6 hours ago, no fever or low grade fever Exclusion criteria: infants and children that use any antivomiting drugs, Any chronic disease, Alarm signs such as headache or abdominal distension, Severe dehydration or shock, Sever diarrhea more than one episode in an hour, Any previous unfavorable response to 5HT3 receptor inhibitor drugs, Any situation that ORT is not recommended

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Vomiting. Timepoint: 4 hours and 48 hours after oral ondansetron administration. Method of measurement: Direct inspection and asking patient`s parents.	—

Secondary

Measure	Time frame
Bradycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Skin rash. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Tachycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Headache. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: History.;Diarrhea. Timepoint: 4 hours after oral ondansetron administration. Method of measurement: History.	—

Measure

Time frame

Bradycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Skin rash. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Tachycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination.;Headache. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: History.;Diarrhea. Timepoint: 4 hours after oral ondansetron administration. Method of measurement: History.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Badeli

17 shahrivar hospital

badeli@gums.ac.ir+98 13 1322 9523

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026