Effect of oral ondansetron ( reduces vomiting and nausea) in improving outcomes in children aged 6 months to 10 years with loose stools and at least 1 episode of vomiting.

Effect of single dose oral ondansetron on outcome in children aged 6 months- 10 years with acute gastroenteritis and some dehydration

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010091

Enrollment

106

Registered

2017-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- children aged 3 months to 10 years admitted with acute gastroenteritis with some dehydration Health Condition 2: A09- Infectious gastroenteritis and colitis, unspecified

Interventions

Intervention1: Ondansetron: Ondansetron is a serotonin 5HT3 receptor antagonist. Used to prevent nausea and vomiting. Drug shall be administered as a single dose of 0.2 mg/kg . Route of administration

Eligibility

Inclusion criteria

Inclusion criteria: children aged 3 months- 10 years with clinical diagnosis of acute gastroenteritis with some dehydration with atleast 1 episode of vomiting

Exclusion criteria

Exclusion criteria: antiemetics in preceding 6 hours underlying chronic disease severe dehydration shock state requiring immediate iv fluids known sensitivity to 5HT receptor antagonists

Design outcomes

Primary

Measure	Time frame
To evaluate whether a single dose oral Ondansetron versus placebo decreases the failure rate of oral rehydration therapy and increases ORS intake in children aged 6 months to 10 years with acute gastroenteritis with some dehydrationTimepoint: dehydration is assessed at 0 hour, 1 hour, 2 hour, 3 hour, 4 hours after initiating rehydration therapy	—

Secondary

Measure	Time frame
To evaluate the role of a single dose oral Ondansetron versus placebo in reducing number of vomiting episodes, decreasing need for Iv fluids, Improving caregiver satisfactionTimepoint: 4 hours after administration of drug/placebo	—

Countries

India

Contacts

Public ContactDr Tejasvi S

JSS HOSPITAL

tejasviseshadri@gmail.com9880629506

Outcome results

None listed

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