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

Protocol summary

Summary
Acute gastroenteritis is one of the most common complaints in children referred to the emergency department. In the disease, vomiting can lead to dehydration, electrolyte disturbances, and even hospitalization. Ondansetron is one of the drugs used to treat vomiting. The aim of this study is to compare the effect of ondansetron in reducing vomiting by oral and intramuscular administration methods. This study is a randomized double-blind clinical trial. In the study, 100 children aged 1-10 years old with acute gastroenteritis that referred to Bahrami Children’s Hospital in Tehran, were enrolled. The inclusion criteria: Children aged 1 to 10 years with acute gastroenteritis and mild to moderate dehydration. The exclusion criteria: The presence of any chronic disease or alarm sign or symptoms such as headache or abdominal distention. 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. 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 the drug. If the child has been tolerated, the treatment is successful and he/she is monitored to up four hours in the emergency department. If there was no vomiting after 4 hours, they will be discharged. Patients were followed up by telephone 48 hours after starting treatment. During this study, they are evaluated for the side effects of ondansetron, including vomiting, headache, and tachycardia. If they had no oral tolerate, they would be hospitalized and treated intravenously rehydration.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082118971N5
Registration date: 2017-09-15, 1396/06/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Kambiz Eftekhari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
k-eftekhari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral Ondansetron vs intramuscular injection in reducing vomiting in Children with acute gastroenteritis referred to pediatric emergency department
Public title
Comparison of the effect of oral ondansetron vs intramuscular injection on vomiting
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Bahrami Children's Hospital
City
TEHRAN
Postal code
1641744991
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2713

Health conditions studied

1

Description of health condition studied
Viral intestinal infection, unspecified
ICD-10 code
A08.4
ICD-10 code description
Viral intestinal infection, unspecified

Primary outcomes

1

Description
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

2

Description
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 outcomes

1

Description
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.

2

Description
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.

Intervention groups

1

Description
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 fluid therapy begins 30 minutes after receiving the drug. If the child has been tolerated, the treatment is successful and he/she is monitored to up four hours in the emergency department. If there was no vomiting after 4 hours, they will be discharged. Patients were followed up by telephone 48 hours after starting treatment.
Category
Treatment - Drugs

2

Description
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 the drug. If the child has been tolerated, the treatment is successful and he/she is monitored to up four hours in the emergency department. If there was no vomiting after 4 hours, they will be discharged. Patients were followed up by telephone 48 hours after starting treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Kambiz Eftekhari
Street address
Kiaee Street, Damavand Street
City
TEHRAN

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Tehran University of Medical Sciences
City
TEHRAN
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bahrami Children's Hospital
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
TEHRAN
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bahrami Children's Hospital
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
TEHRAN
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bahrami Children's Hospital
Full name of responsible person
Kambiz Eftekhari
Position
Assistant professor of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Bahrami Children's Hospital
City
TEHRAN
Postal code
1641744991
Phone
+98 21 7301 3000
Fax
Email
k-eftekhari@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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