Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06175806

Enrollment

160

Registered

2023-12-19

Start date

2023-09-10

Completion date

2023-11-11

Last updated

2023-12-19

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

Conditions

Nausea and Vomiting in Pediatric Age Group

Brief summary

The current clinical trial will include 160 children who will be presented with vomiting to the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams University. Participants will be assigned randomly to receive either a dispersible film Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as the return of appetite and the need for further treatment. The impact of nausea and vomiting on patients' daily lives will be assessed using a modified version of the Functional Living Index-Emesis (FLIE).

Interventions

DRUGOndansetron Oral Film

5-hydroxytryptamine (5-HT) receptor antagonist

DRUGGranisetron Oral Liquid Product

5-hydroxytryptamine (5-HT) receptor antagonist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 14 Years

Healthy volunteers

Inclusion criteria

• Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.

Exclusion criteria

* Patients who are severely dehydrated. * Patients who have bloody vomiting. * Children with chronic diseases like type 1 diabetes mellitus, end stage renal disease and who are receiving chemotherapy. * Patients who have vomiting due to surgical causes like intestinal obstruction.

Design outcomes

Primary

Measure	Time frame	Description
To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.	at 6 hours and at 48 hours of adminsteration	The number of vomiting episodes.

Countries

Egypt

Outcome results

None listed

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