title: The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection.
abstract: OBJECTIVE
  To evaluate the antipyretic efficacy and tolerability of dexibuprofen compared with ibuprofen in children with fever caused by upper respiratory tract infection (URTI).
  
  
  METHODS
  The study population consisted of children aged 6 months to 14 years. At the time of visit to the hospital, the children had fever; the cause of fever was determined to be URTI by a paediatrician based on history taking and physical examination. The study was a multicentre, randomized, double-blind, controlled parallel group, comparative, Phase 3 clinical trial, conducted at three hospitals. By using a computer-based random assignment program, the subjects were allocated to the following three groups: 5 mg kg(-1) dexibuprofen group, 7 mg kg(-1) dexibuprofen group, and 10 mg kg(-1) ibuprofen group.
  
  
  RESULTS
  In the clinical trial of the antipyretic action of dexibuprofen in patients with fever caused by URTI, there was no statistically significant difference in maximal decrease of temperature and mean time to become apyrexial among the 5 mg kg(-1) dexibuprofen, 7 mg kg(-1) dexibuprofen and 10 mg kg(-1) ibuprofen groups (P > 0.05). There also was no significant difference in adverse drug reaction (P > 0.05).
  
  
  CONCLUSIONS
  Dexibuprofen is as effective and tolerable as ibuprofen. A dose of 5 mg kg(-1) and 7 mg kg(-1) dexibuprofen in place of 10 mg kg(-1) ibuprofen would be sufficient to control fever caused by URTI in children.
authors.affiliation: Department of Paediatrics, College of Medicine, the Catholic University of Korea, Seocho-Gu, Seoul, Korea.
authors.forename: Jong Seo
authors.initials: JS
authors.lastname: Yoon
authors.forename: Dae-Chul
authors.initials: DC
authors.lastname: Jeong
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Oh
authors.forename: Keun Young
authors.initials: KY
authors.lastname: Lee
authors.forename: Hyun Seung
authors.initials: HS
authors.lastname: Lee
authors.forename: Young Yull
authors.initials: YY
authors.lastname: Koh
authors.forename: Jin Tack
authors.initials: JT
authors.lastname: Kim
authors.forename: Jin Han
authors.initials: JH
authors.lastname: Kang
authors.forename: Joon Sung
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000493:pharmacokinetics*; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C539402:dexibuprofen; D007052:Ibuprofen