Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm I (group A) who will receive dispersible film ondansetron | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron Oral Film | Drug | 5-hydroxytryptamine (5-HT) receptor antagonist |
|
| 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 |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamed F Allam, MD | Professor of Family Medicine, Faculty of Medicine, Ain shams University | Principal Investigator |
| May F Nassar, MD | Professor of pediatrics, Faculty of Medicine, Ain shams University | Study Director |
| Ehab K Emam, MD | Professor of pediatrics, Faculty of Medicine, Ain shams University | Study Chair |
| Haya E Ibrahim, MD | lecturer of pediatrics,Faculty of Medicine, Ain shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine-Ain Shams University | Cairo | Abbasia | 1181 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Granisetron Oral Liquid Product | Drug | 5-hydroxytryptamine (5-HT) receptor antagonist |
|