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IRCT20180521039763N3 IRCT 2019-09-04 Kerman University of Medical Sciences The effect of Acetaminophen-Ibuprofen combination on pain relief regarding the prescription time Comparison of the effect of Acetaminophen-Ibuprofen combination on pain relief following primary tooth extraction regarding the prescription time in 6-12 year old children in Kerman,Iran 2019-07-21 anticipated 120 Complete https://irct.ir/trial/36962 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Random allocation rule has been used.(Reference:Mohammadi M, Janani L. Randomization in randomized clinical Trials: from theory to practice). Based on the number of participants, provide one form and we have 120 forms totally which putting in on file.Then according to the patient entrance, one of the forms will be raised consecutively, Blinding description: Acetaminophen-Ibuprofen combination or placebo(Neurobion forte-vit B Complex vita B12) in form of syrup will be given to each group. Each child will have a code and will be known with this code in information form. Analyzer will analysis data according to these codes. 3 The effect of Acetaminophen-Ibuprofen combination on relieving pain before and after extraction. Intervention 1: Intervention group: First group, 1 hour before extraction, dose of Acetaminophen-Ibuprofen will be indicated according to exact weight which will be calculated with digital scale .(Personal Scale Business counting Digital Scale,KG180) Ibuprofen suspension( Ibuprofen,Alborzrdarou Co,Iran 100mg/5ml Susp) in dose of 2.5mg/kg and Acetaminophen syrup( Acetaminophen, syrup,60mg/5ml, Ramofarmin Co,Iran)in dose of 7.5mg/kg will be calculated. Second group: 1 hour after extraction, dose of Acetaminophen-Ibuprofen combination similar to first group will be calculated and indicated. Intervention 2: Control group:First group, placebo as syrup(Neurobion forte-vit B lComplex vita B12, OTC Pharmaceutical Products. www.otcpharmausa) 16 Oz,/ 473ml with the same dose of Acetaminophen-Ibuprofen combination will be indicated one hour before extraction.Second group: one hour after extraction will be given. Yes - There is a plan to make this available What will be shared: All data is shared by non-identifiable participants When: 6 months after printing result To whom: People working in academic centers Conditions: The use of information is permitted for more comprehensive research Where to obtain: Shokrizadeh Mahboobeh, Jahanimoghadam Fatemeh How to obtain: After reviewing the request masseage, information is provided to them Comments:
public Fatemeh Jahanimoghadam
Shafa Ave, Jomhuri Blvd
Kerman Iran (Islamic Republic of) 7618819949 +98 34 3211 8071 Fatemehjahani4@gmail.com Kerman University of Medical Sciences scientific Fatemeh Jahanimoghadam
Shafa Ave, Jomhuri Blvd
Kerman Iran (Islamic Republic of) 7618819949 +98 34 3212 7557 Fatemehjahani4@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 6-12 year- old children Without any systemic diseases The children have sufficient physical growth and mental development. Be cooperative 6 years 12 years Both Children with liver,renal,gastric disorders and colitis History of corticosteroid or/and pain reliever use in recent 24 hours. Treatment - Drugs Treatment - Drugs Intervention group: First group, 1 hour before extraction, dose of Acetaminophen-Ibuprofen will be indicated according to exact weight which will be calculated with digital scale .(Personal Scale Business counting Digital Scale,KG180) Ibuprofen suspension( Ibuprofen,Alborzrdarou Co,Iran 100mg/5ml Susp) in dose of 2.5mg/kg and Acetaminophen syrup( Acetaminophen, syrup,60mg/5ml, Ramofarmin Co,Iran)in dose of 7.5mg/kg will be calculated. Second group: 1 hour after extraction, dose of Acetaminophen-Ibuprofen combination similar to first group will be calculated and indicated. Control group:First group, placebo as syrup(Neurobion forte-vit B lComplex vita B12, OTC Pharmaceutical Products. www.otcpharmausa) 16 Oz,/ 473ml with the same dose of Acetaminophen-Ibuprofen combination will be indicated one hour before extraction.Second group: one hour after extraction will be given. Pain relief rate. Timepoint: Immediately after extraction until the next 24 hours. Method of measurement: According to Visual Analigue Scale(VAS). The effect of age,gender on Acetaminophen-Ibuprofen combination. Timepoint: During filling the questionare. Method of measurement: Age will be calculated according to birth year/Gender aacording to observation. Kerman University of Medical Sciences Approved 2019-02-23 Ethics committee of Kerman university of medical Shafa Ave, Jomhuri Blvd Kerman Kerman Iran (Islamic Republic of)