Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

Ain Shams University

Status: Completed

Conditions: Nausea and Vomiting in Pediatric Age Group

Treatments: Drug: Granisetron Oral Liquid Product; Drug: Ondansetron Oral Film

Study type: Interventional

Funder types: Other

Identifiers

NCT06175806

FMASU MS 519/2023

Details and patient eligibility

About

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).

Enrollment: 160 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

arm I (group A) who will receive dispersible film ondansetron

Experimental group

Description:

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.

Treatment:

Drug: Ondansetron Oral Film

Arm II (group B) who will receive oral Granisetron

Experimental group

Description:

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.

Treatment:

Drug: Granisetron Oral Liquid Product