Comparison of the effect of oral ondansetron vs intramuscular injection on vomiting
Not Applicable
Recruiting
- Conditions
- Viral intestinal infection, unspecified.Viral intestinal infection, unspecified
- Registration Number
- IRCT2017082118971N5
- Lead Sponsor
- Vice Chancellor of Research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
The inclusion criteria: Children aged 1 to 10 years with acute gastroenteritis and mild to moderate dehydration; The vomiting has started in the last 24 hours; There is at least one episode of vomiting, within the last 6 hours; The disease is feverless or has a mild fever (below 38 ° C of axillary).
The exclusion criteria: Children who have received any antiemetic drugs within the last 6 hours; The presence of any chronic disease or alarm sign or symptoms such as headache or abdominal distention; There is severe dehydration or shock; Diarrhea is intense and has a frequency of more than once per hour; The patient has a history of any hypersensitivity to 5-HT3 receptor antagonists.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vomiting. Timepoint: 30 minutes after receiving ondancetron, then 4 hours later in the emergency department, then 48 hours after the administration of drug in home. Method of measurement: Direct view and parent question.;Require hospitalization. Timepoint: 30 minutes after receiving ondancetron, then 4 hours later in the emergency department, then 48 hours after the administration of drug in home. Method of measurement: Direct view and parent question.
- Secondary Outcome Measures
Name Time Method Headache. Timepoint: 4 hours after receiving ondancetron in the emergency department. Method of measurement: In children older than 4 years of age, through questions from the children and their parents. In children younger than 4 years, there is an increase in restlessness and irritability through direct observation and asking from their parents.;Tachycardia. Timepoint: 4 hours after receiving ondancetron in the emergency department. Method of measurement: Using auscultation by therapist with stethoscope. In children 1-3 years, the palse rate more than 150 beats per minute, in 4 - 5 years old more than 135, in 6 - 8 years old more than 130 and in 8 - 10 years old more than 110 are abnormal and and considered to be tachycardia.