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IRCT20090909002438N3 IRCT 2019-07-04 Guilan University of Medical Sciences The effect of diclofenac on the treatment of fever in children Comparison of the effect of rectal diclofenac and high dose rectal acetaminophen on fever among children 2019-06-22 anticipated 90 Complete https://irct.ir/trial/39216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The patient is not aware of the type of medication he receives, nor is the person who measures the temperature. 3 Fever. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Individual data related to primary outcome can be shared after making the data anonymous When: Starting 6 months after publication To whom: Only available for people working in academic institutions. Conditions: The use of data from this study is permitted for academic use and should be cited in the paper. Where to obtain: Request only by email to researcher: hashemian@gums.ac.ir How to obtain: 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. Comments:
public Houman Hashemian
Pediatric Diseases Research Center, 17 Shahrivar Hospital, Shahid Siadati street, Namjoo street
Rasht Iran (Islamic Republic of) 4144654679 +98 13 3336 9002 hashemian@gums.ac.ir Guilan University of Medical Sciences scientific Houman Hashemian
Pediatric Diseases Research Center, 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St., Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654679 +98 13 3336 9002 hashemian@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) 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 1 year 6 years Both 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 R50.9 Fever, unspecified Treatment - Drugs Treatment - Drugs 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. 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. 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. Guilan University of Medical Sciences Approved 2019-03-16 Research Ethics Committee of Guilan University of Medical Sciences Vice-chancellor for Research, Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street Rasht Guilan Iran (Islamic Republic of)