Abstract
The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen. 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. 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. Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.
Published Version
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