The effect of single and two doses ranitidine on nausea and morning abdominal pain in children
Design
In this study, the samples were selected among 3-15 year old children who were referred by parents to Hospital, with nausea and abdominal pain
.minimum of 3 years were considered as the minimum age because children under 3 years of age were not able to express problems and complaints, and 15 years were considered as the maximum age range for pediatric patients.
Due to the fact that patients are all referred with complaints of pain, administration of placebo is unacceptable. The subjects were randomly divided into two intervention groups including group 1 (treated with single dose ranitidine) and group 2 (ranitidine Bid). The two groups are matched in terms of age and gender. For each child, ranitidine is prescribed for a period of 4 weeks. In group 1, ranitidine was given a single dose of 2 mg/ kg before bed and in group 2, 2 mg/kg will be given twice daily to patients. Patients in each group in the second and sixth weeks after starting treatment are evaluated for the improvement of symptoms.
Settings and conduct
gorgan taleghani hospital
Participants/Inclusion and exclusion criteria
inclusion criteria in the study includes persistent or intermittent pain in the morning for more than two weeks at the upper abdominal area or nausea in the morning which has no non-GI cause and age between the of 15-3 years.
Intervention groups
effect of ranitidine single or two doses on children aged 3 to 15 years old with a complaint of nausea and abdominal pain in the morning.
Main outcome variables
Improve the pain and morning nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171211037830N2
Registration date:2018-07-05, 1397/04/14
Registration timing:retrospective
Last update:2018-07-05, 1397/04/14
Update count:0
Registration date
2018-07-05, 1397/04/14
Registrant information
Name
Mohammad Sobhani Shahmirzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 8435
Email address
sobhani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
Comparison of the effect of single and twice daily administration of ranitidine in relief of morning abdominal pain and nausea in children
Public title
Comparison of the effect of single and twice daily administration of ranitidine in relief of morning abdominal pain and nausea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
abdominal pain and nausea
Exclusion criteria:
Nausea caused by extra-digestive system causes
Age
From 3 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Hirkan Blvd,Gorgan
City
Gorgan
Province
Golestan
Postal code
4916668197
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
Ir.Goums.REC.1396.240
Health conditions studied
1
Description of health condition studied
abdominal pain and nausea
ICD-10 code
R10.9
ICD-10 code description
Unspecified abdominal pain
Primary outcomes
1
Description
improvement in abdominal pain
Timepoint
Two weeks and four weeks after starting treatment
Method of measurement
Question from parents
2
Description
improvement in nausea
Timepoint
Question from parents
Method of measurement
improvement in nausea
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: single dose ranitidine
Category
Treatment - Drugs
2
Description
Intervention group: two dose ranitidine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Children Hospital in Gorgan
Full name of responsible person
Mohammad Sobhani Shahmirzadi
Street address
Taleghani Hospital, janbazan Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3232 5423
Email
sobhani@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Golestan University of Medical Sciences
Full name of responsible person
Mohammad Sobhani Shahmirzadi
Street address
Janbazan boulvard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3252 8435
Email
sobhani@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Golestan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Sobhani Shahmirzadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Edalat 91
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3252 8435
Email
sobhani@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Sobhani Shahmizaii
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital, Veterans Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3252 8435
Email
sobhani@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Sobhani Shahmizadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital, janbazan Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3252 8435
Email
sobhani@goums.ac.ir
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