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Ondansetrin in pediatruc Gastroentritis

Investigating the effectiveness of a single dose of ondansetron in reducing the need for hospitalization or intravenous fluid therapy in children with gastroenteritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220128053852N1
Enrollment
30
Registered
2023-03-04
Start date
2023-03-21
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Acute gastroentritis in children. Viral intestinal infection, unspecified

Interventions

Intervention 1: Control group: 5 cc of placebo that is as similar in appearance, color, and taste as possible to the original drug. The placebo drug will be prepared by the pharmacy of Dr. Sabzeqabae

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 60 Months

Inclusion criteria

Inclusion criteria: Age between 6 and 60 months At least once watery and loose diarrhea in 24 hours Vomiting at least once in the last 4 hours Patients with mild to moderate dehydration

Exclusion criteria

Exclusion criteria: Severe dehydration or hypovolemic shock Surgical causes of vomiting Adverse drug reaction to Ondansetron Bloody vomiting Severe abdominal distention or ileous Congenital or aquired cardiac diseases Under 6 months infants Bloody stool

Design outcomes

Primary

MeasureTime frame
The need for intravenous fluid therapy. Timepoint: During the first 4 hours of receiving the drug and placebo, the patient's symptoms are evaluated every hour. Method of measurement: Clinical judgment of the doctor and the degree of dehydration of the patient.

Secondary

MeasureTime frame
Repeated vomiting. Timepoint: First 4 hours after intervention. Method of measurement: History taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMinoo Saeidi

Esfahan University of Medical Sciences

minoo.saeidi@gmail.com+98 31 3668 0048

Outcome results

None listed

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