To comparing high-dose rectal acetaminophen and diclofenac suppository in controlling children's fever.
Design
The present study is a double blind clinical trial study. Patients will be randomly divided into two groups of 45 children. All children aged 1 to 6 years who meet the inclusion criteria will be included in the study based on 22 random blocks of size 4 and one block of size 2 in a sealed envelope. The name of children will be expelled from the envelopes gradually. The patient is not aware of the type of medication he receives, nor is the person who measures the temperature.
Settings and conduct
The present study is carried out at 17th Shahrivar Hospital in Rasht- Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 1 to 6 years old; at least 10 kg weight; fever between 39-40.5 ° C rectal temperature lasted for less than 4 days.
Non-inclusion criteria: History of chronic disease; recent use of antipyretic drugs or antibiotics
Intervention groups
Intervention group 1: These children will receive high dose acetaminophen suppositories at a dose of 30mg / kg.
Intervention group 2: These children will receive diclofenac suppositories at a dose of 1mg / kg.
Main outcome variables
The patient's rectal temperature after one and three hours of intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090909002438N3
Registration date:2019-07-04, 1398/04/13
Registration timing:registered_while_recruiting
Last update:2019-07-04, 1398/04/13
Update count:0
Registration date
2019-07-04, 1398/04/13
Registrant information
Name
Houman Hashemian
Name of organization / entity
Guilan University of medical sciences- Medical faculty- 17 Shahrivar hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9061
Email address
hashemian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rectal diclofenac and high dose rectal acetaminophen on fever among children
Public title
The effect of diclofenac on the treatment of fever in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 1 to 6 years old
at least 10 kg weight
Fever between 39-40.5 ° C of rectal temperature lasted for less than 4 days
Exclusion criteria:
Diarrhea in the last 24 hours
History of previous sensitivity to acetaminophen and diclofenac
History of malignancy
History of renal failure
History of liver failure
History of neurological disease or febrile convulsion within the past hour, or loss of consciousness or known vasculitis
Use of antipyretic over the past 8 hours
Use of antibiotics within the past 8 hours or 3 hours after the administration of the active antipyretic drug (acetaminophen or diclofenac)
History of Hyper Reactive Airway Disease
History of gastritis and peptic ulcer
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups of 45 children. All children aged 1 to 6 years who meet the inclusion criteria will be included in the study based on 22 random blocks of size 4 and one block of size 2 in a sealed envelope. The name of children will be expelled from the envelopes gradually.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the type of medication he receives, nor is the person who measures the temperature.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Guilan University of Medical Sciences
Street address
Vice-chancellor for Research, Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654679
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.GUMS.REC.1397.504
Health conditions studied
1
Description of health condition studied
Fever
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified
Primary outcomes
1
Description
Rate of patient temperature
Timepoint
Measure the temperature of the patients before, one and three hours after the intervention
Method of measurement
Digital rectal thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: These children will receive acetaminophen suppository at a dose of 30 mg / kg. The acetaminophen suppositories 125 and 325 mg are manufactured by Daroupakhsh Pharmaceutical MFG Co., Lot/Batch Number: 304 & 622, respectively. Based on the child’s weight, the suppositories will be cut off of length according to the required amount and will be weighted by a digital scale (Notebook series- Model: 1108-2 manufactured by Shenzhen Big Dipper Co., LTD., China); and then will be used. The rectal temperature of the patients will be measured before and then, one and three hours after the intervention, using the Beurer Digital Thermometer, FT15 / 1, manufactured by Beurer GmbH, Germany.
Category
Treatment - Drugs
2
Description
Intervention group: These children will receive diclofenac suppository at a dose of 1 mg / kg. The diclofenac suppositories 50 mg are manufactured by Daroupakhsh Pharmaceutical MFG Co., Lot/Batch Number: 873. Based on the child’s weight, the suppositories will be cut off of length according to the required amount and will be weighted by a digital scale (Notebook series- Model: 1108-2 manufactured by Shenzhen Big Dipper Co., LTD., China); and then will be used. The rectal temperature of the patients will be measured before and then, one and three hours after the intervention, using the Beurer Digital Thermometer, FT15 / 1, manufactured by Beurer GmbH, Germany.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17th Shahrivar Hospital
Full name of responsible person
Houman Hashemian
Street address
17th Shahrivar Hospital, Shahid Siadati street, Namjoo street
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9061
Email
17shahrivar@gums.ac.ir
Web page address
http://www.gums.ac.ir/17shahrivar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shademan Nemati
Street address
Vice-chancellor for Research, Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Pediatric Diseases Research Center, 17 Shahrivar Hospital, Shahid Siadati street, Namjoo street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Email
hashemian@gums.ac.ir
Web page address
http://www.gums.ac.ir/prc/default.aspx?tabid=3278
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Pediatric Diseases Research Center, 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Email
hashemian@gums.ac.ir
Web page address
http://www.gums.ac.ir/prc/default.aspx?tabid=3278
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Pediatric Diseases Research Center, 17 Shahrivar Hospital, Shahid Siadati street, Namjoo street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Email
hashemian@gums.ac.ir
Web page address
http://www.gums.ac.ir/prc/default.aspx?tabid=3278
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data related to primary outcome can be shared after making the data anonymous
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Only available for people working in academic institutions.
Under which criteria data/document could be used
The use of data from this study is permitted for academic use and should be cited in the paper.
From where data/document is obtainable
Request only by email to researcher: hashemian@gums.ac.ir
What processes are involved for a request to access data/document
The request must be submitted with the full individual and academic information of the applicant. Then the case is presented to the research committee at the presence of all the researchers and the data will be sent if approved.