Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

December 8, 2023 updated by: Haya Essam Ibrahim, Ain Shams University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 1181
        • Faculty of Medicine-Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm I (group A) who will receive dispersible film ondansetron
arm I (group A) who will receive dispersible film ondansetron in a dose of 4 mg for those who will weigh more than 15 Kg up to 30 kg, and 8 mg for those who will weigh more than 30 Kg. The dose will be repeated if the patient had another vomiting episode within 15 minutes of taking the medicine.
Drug: Ondansetron Oral Film
5-hydroxytryptamine (5-HT) receptor antagonist
Experimental: Arm II (group B) who will receive oral Granisetron
Arm II (group B) who will receive oral Granisetron in a dose of 40 microgram/kg/dose; the dose could be repeated if needed after 12 hours.
Drug: Granisetron Oral Liquid Product
5-hydroxytryptamine (5-HT) receptor antagonist

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Mohamed F Allam, MD, Professor of Family Medicine, Faculty of Medicine, Ain shams University
  • Study Director: May F Nassar, MD, Professor of pediatrics, Faculty of Medicine, Ain Shams University
  • Study Chair: Ehab K Emam, MD, Professor of pediatrics, Faculty of Medicine, Ain Shams University
  • Principal Investigator: Haya E Ibrahim, MD, lecturer of pediatrics,Faculty of Medicine, Ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2023

Primary Completion (Actual)

November 11, 2023

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 519/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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