Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group
- Conditions
- Nausea and Vomiting in Pediatric Age Group
- Interventions
- Registration Number
- NCT06175806
- Lead Sponsor
- Ain Shams University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
• Patients presenting with vomiting within the past 24 hours, including patients without dehydration and those who have mild to moderate dehydration.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm I (group A) who will receive dispersible film ondansetron Ondansetron Oral Film 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. Arm II (group B) who will receive oral Granisetron Granisetron Oral Liquid Product 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Medicine-Ain Shams University
🇪🇬Cairo, Abbasia, Egypt