Determination of response to omeprazole treatment in children with non-cardiac chest pain referred to Amir Kabir Hospital, Arak, Iran, 1997
Design
A single-blind randomized clinical trial study will be conducted on 144 children and adolescents aged 5-18 years with non-cardiac chest pain. Patients with inclusion criteria will be divided into two groups of 74 by using randomized block design. The first group will be children who will be considered as intervention group. One course of omeprazole 1mg / kg daily. A number is given before breakfast for two weeks. The second group includes children who will be considered as a control group and will be given placebo for the same period. After a 2-week study period, patients will be followed up and rechecked to determine if this treatment has been helpful.
Settings and conduct
A single-blind study is performed on patients referred to Amir Kabir Hospital in Arak. Children with non-cardiac chest pain were randomly assigned into two groups of omeprazole and control groups.
Children and their families are not aware of the study group. Follow-up and response to treatment are also based on a checklist prepared on the first, seventh, and fourth days.
Participants/Inclusion and exclusion criteria
Chest pain in this study was continuous or recurrent pain that lasted for at least 2 weeks and for a maximum of 8 weeks. Children with a history of chest trauma or point tenderness will be excluded.
Intervention groups
The first group consists of children who will be considered as the intervention group. One course of omeprazole 1mg / kg daily is given one day before breakfast for two weeks. And they will be given placebo for the same period.
Main outcome variables
Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045655N1
Registration date:2019-12-25, 1398/10/04
Registration timing:retrospective
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Vahid Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 5904
Email address
vahid.heidari8818@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
2018-12-06, 1397/09/15
Actual recruitment end date
2019-03-11, 1397/12/20
Trial completion date
2019-03-11, 1397/12/20
Scientific title
Evaluation of responses to Omeprazole treatment in children with non-cardiac chest pain
Public title
The effect of omeprazole on pediatric chest pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kids 5-18 years old
Complain chest pain that lasts for at least 2 weeks
Exclusion criteria:
cardiac chest pain
Patient unwillingness to continue collaborating in the study
Duration of pain more than 8 weeks
History of trauma to the chest
point tenderness
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
144
Actual sample size reached:
144
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 144 patients, aged 5-18 years, referred to Amir Kabir Hospital in Arak, complaining of chest pain and having inclusion criteria, after obtaining informed consent. Patients were then randomly divided into two groups of omeprazole and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind randomized clinical trial in which children with non-cardiac chest pain will be divided into two equal groups. The first group is children who will be considered as the intervention group and will be given a course of treatment with omeprazole. The second group includes children who will be treated as a control group and given placebo for the same period. The blinding method in this study is that the children and their families are not aware of the study group. But the physician, clinician, and data analyst know the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam University Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.ARAKMU.REC.1397.113
Health conditions studied
1
Description of health condition studied
Non-cardiac Chest Pain
ICD-10 code
R07.9
ICD-10 code description
Chest pain, unspecified
Primary outcomes
1
Description
Chest pain
Timepoint
First, seventh and fourteenth days
Method of measurement
Visual Analogue Scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A course of treatment with omeprazole at a dose of 1mg / kg daily is prescribed for one week before breakfast for two weeks.
Category
Treatment - Drugs
2
Description
Control group: A placebo is given one number before breakfast for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Vahid Heydari
Street address
Shiruodi St., Parastar Ave.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Univercity Complex, Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Heydari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bustan8 Alley, Abureyhan St., Mustafa-khomeini Town
City
Arak
Province
Markazi
Postal code
3818833516
Phone
+98 86 3367 5904
Email
vahid.heidari8818@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Heydari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Bustan8 Alley, Abureyhan St., Mustafa-khomeini Town
City
Arak
Province
Markazi
Postal code
3818833516
Phone
+98 86 3367 5904
Email
vahid.heidari8818@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Heydari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bustan8 Alley, Abureyhan St., Mustafa-khomeini Town
City
Arak
Province
Markazi
Postal code
3818833516
Phone
+98 86 3367 5904
Email
vahid.heidari8818@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available