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IRCT138710221545N1 IRCT 2011-02-26 Vice Chancellor for research, Guilan University of Medical Sciences Effect of oral Ondansetron on Decreasing the Vomiting Associated With Acute Gastroenteritis in pediatrics Effect of oral Ondansetron on Decreasing the Vomiting Associated With Acute Gastroenteritis in pediatrics 2010-12-22 anticipated 176 Complete https://irct.ir/trial/828 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Acute gastroenteritis. Intervention 1: Ondansetron tablets, 30 minutes before ORT, with dosage adjusting based on patient`s weight ( Using ondansetron 4 mg tablets ). Intervention 2: Placebo tablets, 30 minutes before ORT.
public Hamidreza Badeli
17 shahrivar Hospital. Namjoo street
Rasht Iran (Islamic Republic of) +98 13 1322 9523 badeli@gums.ac.ir 17 shahrivar hospital scientific Hamidreza badeli
17 shahrivar Hospital. Namjoo street
Rasht Iran (Islamic Republic of) +98 13 1322 9523 badeli@gums.ac.ir 17 shahrivar hospital Iran (Islamic Republic of) Inclusion criteria: age 1 to 10 years old, Simple acute gastroenteritis, mild to moderate dehydration, Onset of disease in 24 hours prior to the study, At least one episode of vomiting in 6 hours ago, no fever or low grade fever Exclusion criteria: infants and children that use any antivomiting drugs, Any chronic disease, Alarm signs such as headache or abdominal distension, Severe dehydration or shock, Sever diarrhea more than one episode in an hour, Any previous unfavorable response to 5HT3 receptor inhibitor drugs, Any situation that ORT is not recommended 1 year 10 years Both A09 Diarrhoea and gastroenteritis of presumed infectious origin Treatment - Drugs Placebo Ondansetron tablets, 30 minutes before ORT, with dosage adjusting based on patient`s weight ( Using ondansetron 4 mg tablets ) Placebo tablets, 30 minutes before ORT Vomiting. Timepoint: 4 hours and 48 hours after oral ondansetron administration. Method of measurement: Direct inspection and asking patient`s parents. Bradycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination. Skin rash. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination. Tachycardia. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: Physical examination. Headache. Timepoint: 4 hors after oral ondansetron administration. Method of measurement: History. Diarrhea. Timepoint: 4 hours after oral ondansetron administration. Method of measurement: History. Vice Chancellor for research, Guilan University of Medical Sciences Approved 2010-09-28 Vice Chancellor for research, Guilan University of Medical Sciences Vice Chancellor for research, Guilan University of Medical Sciences, Mellat Street, Namjoo Avenue Rasht Iran (Islamic Republic of)