MedTrace Logo

Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

NCT06175806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-12-19

No results posted yet for this study

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).

Conditions

  • Nausea and Vomiting in Pediatric Age Group

Interventions

DRUG

Ondansetron Oral Film

5-hydroxytryptamine (5-HT) receptor antagonist

DRUG

Granisetron Oral Liquid Product

5-hydroxytryptamine (5-HT) receptor antagonist

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohamed F Allam, MD · Professor of Family Medicine, Faculty of Medicine, Ain shams University

  • May F Nassar, MD · Professor of pediatrics, Faculty of Medicine, Ain shams University

  • Ehab K Emam, MD · Professor of pediatrics, Faculty of Medicine, Ain shams University

  • Haya E Ibrahim, MD · lecturer of pediatrics,Faculty of Medicine, Ain shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-10
Primary Completion
2023-11-11
Completion
2023-11-11

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175806 on ClinicalTrials.gov