Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

Ain Shams University160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Nausea and Vomiting in Pediatric Age Group

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: at 6 hours and at 48 hours of adminsteration