title: Dexibuprofen for fever in children with upper respiratory tract infection.
abstract: BACKGROUND
  The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen.
  
  
  METHODS
  This double-blind, double-dummy study enrolled patients from January 2008 to May 2009 presenting at one of five tertiary care centers in Seoul, Korea with febrile illness who were then given one of three active treatments: one dose of dexibuprofen 2.5 or 5 mg/kg (DEX 1); dexibuprofen 3.5 or 7 mg/kg (DEX 2); or ibuprofen 5 or 10 mg/kg (control) syrup. Those with a temperature <38.5°C were given the lower dose. Temperature was measured every hour for 4 h. Primary study outcome was mean change in temperature 4 h after one dose.
  
  
  RESULTS
  A total of 264 children (aged 6 months-14 years) with febrile illness due to upper respiratory tract infection were consecutively sampled and screened, with 260 randomized. No patients withdrew due to adverse effects. Mean temperature change after 4 h (mean ± SD: DEX 1, 0.99 ± 0.84°C; DEX 2, 1.12 ± 0.92°C; control, 1.38 ± 0.84°C) differed only between DEX 1 and controls (P = 0.007, 95% confidence interval [CI]: -0.61 to -0.15). When groups were subdivided according to initial temperature, there were no significant differences in mean temperature change after 4 h between DEX 2 subgroups (<38.5°C, 0.88 ± 0.86°C; ≥38.5°C, 1.46 ± 0.90°C) and controls (1.07 ± 0.84°C and 1.72 ± 0.91°C, respectively), but there was a significant difference between DEX 1 (≥38.5°C, 1.25 ± 0.76°C) and controls (P = 0.0222, 95%CI: -0.80 to -0.13). There were no significant differences in adverse events among groups.
  
  
  CONCLUSIONS
  Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.
authors: Department of Pediatrics, Asthma and Allergy Center, Inje University Sanggye Paik Hospital, Seoul, Korea. kimck@paik.ac.kr
authors: Chang-Keun
authors: CK
authors: Kim
authors: Zak
authors: Z
authors: Callaway
authors: Ji Tae
authors: JT
authors: Choung
authors: Jin Ho
authors: JH
authors: Yu
authors: Kye Shik
authors: KS
authors: Shim
authors: Eun-Mi
authors: EM
authors: Kwon
authors: Young Yull
authors: YY
authors: Koh
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001831:Body Temperature / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005500:Follow-Up Studies; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C539402:dexibuprofen; D007052:Ibuprofen
keywords: dexibuprofen; fever; ibuprofen; randomized controlled trial; upper respiratory tract infection