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Completed

NCT Number: NCT06175806

Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

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).

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Key information

Conditions

Nausea and Vomiting in Pediatric Age Group Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron Oral Film

Drug

5-hydroxytryptamine (5-HT) receptor antagonist

Granisetron Oral Liquid Product

Drug

5-hydroxytryptamine (5-HT) receptor antagonist

Primary outcomes

  1. To compare the effectiveness of Granisetron oral solution and Ondansetron oral dispersible film for treatment of vomiting in pediatric patients.

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

    The number of vomiting episodes.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Oral Granisetron Versus Oral Ondansetron for Treatment of Gastroenteritis: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 19, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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