Objective: comparing the effect of Ranitidin and Pantoprazole on PICU patients in Imam hossein hospital.
Inclusion criteria: pediatric patient aged 2months - 15 years old who have parents consent. Exclusion criteria: discharging before the end of the study; any condition that need change the dose of Ranitidin and Pantoprazole e.g GI bleeding. Design: double blind clinical trial. Seventy patients are divided randomly to 2 group(35 patients in each group). Intervention: in ranitidine gruop, amp ranitidine will prescribe 1 mg\kg twice daily for one week; and in pantoprazole group, amp pantoprazole will prescribe 1 mg\kg twice daily for one week. We will check Mg level daily for one week and check Na ,K daily and Ca and PH twice in one week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120330347N1
Registration date:2016-12-03, 1395/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-03, 1395/09/13
Registrant information
Name
Elahe Mansouri
Name of organization / entity
Isfehsn university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3450 1914
Email address
kosar.mansouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Isfahn University of Medical Sciences
Expected recruitment start date
2016-08-17, 1395/05/27
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Ranitidin and Pantoprazole on PICU patients in Imam hossein hospital
Public title
Comparing the effect of Ranitidin and Pantoprazole on Mg level
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: age from 2 months to 15 years old children admited in PICU; consent to participate in the study.
Exclusion criteria: discharging before the end of the study; any condition that need to change the dose of Ranitidin or Pantoprazole for patients e.g GI bleeding.
Age
From 2 months old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Isfahn University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.MUI.REC.1395.3.510
Health conditions studied
1
Description of health condition studied
Magnesium deficiency
ICD-10 code
E61.2
ICD-10 code description
Primary outcomes
1
Description
Magnesium level
Timepoint
Daily since 7 days
Method of measurement
Labratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Ranitidin, IV, 1 mg/ kg, BID, till end of the study
Category
Treatment - Drugs
2
Description
Pantoprazol, IV, BID,1 mg / kg, till end of the study
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Pediatric Center,pediatric intensive care unit
Full name of responsible person
Mohammadreza Habibzade
Street address
Isfahan, lmam khomeini street
City
Isfehan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Mehdi neamatbakhsh
Street address
Isfahn University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahn 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
Isfahn University of Medical Sciences
Full name of responsible person
Elahe Mansouri
Position
Medical student
Other areas of specialty/work
Street address
Isfahn University of Medical Sciences,Hezargarib street, Isfehan
City
Isfehan
Postal code
Phone
+98 31 3450 1914
Fax
Email
Kosar.mansouri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Habibzade
Position
Department of Anesthesiology
Other areas of specialty/work
Street address
Isfahn University of Medical Sciences, Imam khomeini street, lmam hossein hospital
City
Isfehan
Postal code
Phone
+98 31 3450 1914
Fax
Email
habibzadeh@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Elahe Mansouri
Position
Medical stusent
Other areas of specialty/work
Street address
Isfahn University of Medical Sciences, Hezargarib street, lsfrhan
City
Isfahn
Postal code
Phone
+98 31 3450 1914
Fax
Email
kosar.mansouri@gmailL.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)