Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

Study Overview
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Brief Summary
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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).

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

Conditions
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Nausea and Vomiting in Pediatric Age Group

Intervention / Treatment
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* Drug: Ondansetron Oral Film
* Drug: Granisetron Oral Liquid Product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>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<br>* 5-hydroxytryptamine (5-HT) receptor antagonist<br>|
| Experimental: Arm II (group B) who will receive oral Granisetron<br>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<br>* 5-hydroxytryptamine (5-HT) receptor antagonist<br>|

What is the study measuring?
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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. | The number of vomiting episodes. | at 6 hours and at 48 hours of adminsteration |