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Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group

NCT ID: NCT06175806

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2023-11-11

Brief Summary

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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).

Detailed Description

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Conditions

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Nausea and Vomiting in Pediatric Age Group

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Ondansetron Oral Film

Intervention Type DRUG

5-hydroxytryptamine (5-HT) receptor antagonist

Arm II (group B) who will receive oral Granisetron

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.

Group Type EXPERIMENTAL

Granisetron Oral Liquid Product

Intervention Type DRUG

5-hydroxytryptamine (5-HT) receptor antagonist

Interventions

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Ondansetron Oral Film

5-hydroxytryptamine (5-HT) receptor antagonist

Intervention Type DRUG

Granisetron Oral Liquid Product

5-hydroxytryptamine (5-HT) receptor antagonist

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Haya Essam Ibrahim

lecturer of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed F Allam, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Family Medicine, Faculty of Medicine, Ain shams University

May F Nassar, MD

Role: STUDY_DIRECTOR

Professor of pediatrics, Faculty of Medicine, Ain shams University

Ehab K Emam, MD

Role: STUDY_CHAIR

Professor of pediatrics, Faculty of Medicine, Ain shams University

Haya E Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer of pediatrics,Faculty of Medicine, Ain shams University

Locations

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Faculty of Medicine-Ain Shams University

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 519/2023

Identifier Type: -

Identifier Source: org_study_id