Comparing the effect of acetaminophen and Ibuprofen in the treatment of clinical manifestations of pyelonephritis.
Design
This study is a clinical trial in Phase 4. children who have been diagnosed with pyelonephritis, based on urine test findings and DSMA scans, are selected as the study group. In this study, 100 children who have inclusion criteria are included. Patients are randomly and based on block approach assigned into two groups: 50 children in the Ibuprofen group and 50 children in the acetaminophen group. During the treatment, the symptoms of urination are monitored continuously.
Settings and conduct
This study was carried out as a clinical trial at the Pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Patients with pyelonephritis who have clinical symptoms associated with it, according to a certified physician, will be included in this study. Also, children or parents who are reluctant to continue study, will be excluded from our study.
Intervention groups
First group: In the first group, who are taking Ibuprofen, this drug is prescribed at a dose of 7 mg / kg / day every 6-8 hours.
Second group:In the second group of patients taking acetaminophen, this drug is administered at a dose of 10 mg / kg / day every 6-8 hours.
Main outcome variables
Symptoms of Pyelonephritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013366N9
Registration date:2018-04-06, 1397/01/17
Registration timing:prospective
Last update:2018-04-06, 1397/01/17
Update count:0
Registration date
2018-04-06, 1397/01/17
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-18, 1397/01/29
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Acetaminophen and Ibuprofen on the Clinical Manifestations of Pyelonephritis in Children.
Public title
Comparison of the effects of acetaminophen and Ibuprofen on the Clinical Manifestations of Pyelonephritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pyelonephritis and referring with related symptoms
Satisfaction to participate in the study
Exclusion criteria:
Dissatisfied to participate in the study
Age
To 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, based on this two lists of patients are provided and each list is placed in one of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs.
Placebo
Not 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
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-11, 1396/11/22
Ethics committee reference number
IR.ARAKMU.REC.1396.249
Health conditions studied
1
Description of health condition studied
Pyelonephritis
ICD-10 code
N10
ICD-10 code description
Acute tubulo-interstitial nephritis
Primary outcomes
1
Description
Symptoms of Pyelonephritis
Timepoint
Before taking the drug and 14 days after taking medication
Method of measurement
Registration of symptoms in the checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the first group, Ibuprofen is prescribed at a dose of 7 mg / kg / day every 6-8 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group, acetaminophen is administered at a dose of 10 mg / kg / day every 6-8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Dr. Alireza Gholami
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dralirezagh6363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dr.yousefi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?