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IRCT20220128053852N1 IRCT 2023-03-04 Esfahan University of Medical Sciences Ondansetrin in pediatruc Gastroentritis Investigating the effectiveness of a single dose of ondansetron in reducing the need for hospitalization or intravenous fluid therapy in children with gastroenteritis 2023-03-21 anticipated 30 Complete https://irct.ir/trial/68750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: we will use blocked randomisation. Using the Random Allocation software 2.0, for 2 study groups, 10 blocks of 6 were calculated for a sample size of 60 people, and each person will be identified with a unique code (consisting of two letters and a Latin number). To assign the child to each of the 2 study groups, an envelope containing a unique code and treatment group will be delivered to the child's parents. The associate nurse of the plan, who is stationed next to the nurse in charge of fluid therapy, will open the envelope and determine the type of intervention before the patient's admission, Blinding description: We put ondansetron and placebo in identical packages and write code A or B on the package. As much as possible, the appearance of the medicine is not visible to the parents. Only the researcher is aware of which A and B are the intervention group and which is the control group, and the rest of the people involved, including the doctor and the person in charge of data analysis, are not aware. N/A Acute gastroentritis in children. Intervention 1: Control group: 5 cc of placebo that is as similar in appearance, color, and taste as possible to the original drug. The placebo drug will be prepared by the pharmacy of Dr. Sabzeqabaei, a member of the Faculty of Pharmacy Department of Isfahan Pareshki University of Sciences, and it will be prepared as a solution with the color, smell, and consistency as similar as possible to the original drug. Intervention 2: Intervention group: Fifteen hundred milligrams per kilogram of the patient's weight of Andasterone is taken orally for one dose. Ondansetron Syrup is a product of Exir Pharmaceutical Company and contains 4 mg of drug per 5 cc of solution. Yes - There is a plan to make this available What will be shared: All data after de-identification When: 6 months after the results are published To whom: Scientific institutions Conditions: Academic uses by faculty colleagues of universities in Iran or other universities in the world Where to obtain: Email to the research officer at minoo.saeidi@gmail.com How to obtain: Email to the research officer And making decisions depending on the conditions and agreement Comments:
public Minoo Saeidi
Isfahan university of medical sciences
Isfahan Iran (Islamic Republic of) 8174602647 +98 31 3668 0048 minoo.saeidi@gmail.com Esfahan University of Medical Sciences scientific Minoo Saeidi
Hezar jarib
Isfahan Iran (Islamic Republic of) 8174602647 +98 31 3668 0048 minoo.saeidi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 6 and 60 months At least once watery and loose diarrhea in 24 hours Vomiting at least once in the last 4 hours Patients with mild to moderate dehydration 6 months 60 months Both Severe dehydration or hypovolemic shock Surgical causes of vomiting Adverse drug reaction to Ondansetron Bloody vomiting Severe abdominal distention or ileous Congenital or aquired cardiac diseases Under 6 months infants Bloody stool A08.4 Viral intestinal infection, unspecified Placebo Treatment - Drugs Control group: 5 cc of placebo that is as similar in appearance, color, and taste as possible to the original drug. The placebo drug will be prepared by the pharmacy of Dr. Sabzeqabaei, a member of the Faculty of Pharmacy Department of Isfahan Pareshki University of Sciences, and it will be prepared as a solution with the color, smell, and consistency as similar as possible to the original drug. Intervention group: Fifteen hundred milligrams per kilogram of the patient's weight of Andasterone is taken orally for one dose. Ondansetron Syrup is a product of Exir Pharmaceutical Company and contains 4 mg of drug per 5 cc of solution. The need for intravenous fluid therapy. Timepoint: During the first 4 hours of receiving the drug and placebo, the patient's symptoms are evaluated every hour. Method of measurement: Clinical judgment of the doctor and the degree of dehydration of the patient. Repeated vomiting. Timepoint: First 4 hours after intervention. Method of measurement: History taking. Esfahan University of Medical Sciences Approved 2022-10-06 Ethical Committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)