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Comparison of the effect of oral ondansetron vs intramuscular injection on vomiting

Comparison the effect of oral Ondansetron vs intramuscular injection in reducing vomiting in Children with acute gastroenteritis referred to pediatric emergency department

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017082118971N5
Enrollment
100
Registered
2017-09-15
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral intestinal infection, unspecified. Viral intestinal infection, unspecified

Interventions

Intervention 1: The children were divided in two groups in a simple randomized method. The first group was given oral Ondansetron (manufactured by Iranian company, World Health Company) with dose 0.2
Treatment - Drugs
The children were divided in two groups in a simple randomized method. The first group was given oral Ondansetron (manufactured by Iranian company, World Health Company) with dose 0.2 mg/kg. Oral flui
The second group received intramuscular injection of Ondansetron (manufactured by Iranian company, Tehran Chemistry Company) with dose 0.2 mg/kg. Oral fluid therapy begins 30 minutes after receiving t

Sponsors

Vice Chancellor of Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 10 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKambiz Eftekhari

Bahrami Children's Hospital

k-eftekhari@sina.tums.ac.ir+98 21 7301 3000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026