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Dexibuprofen for fever in children with upper respiratory tract infection
Author(s) -
Kim ChangKeun,
Callaway Zak,
Choung Ji Tae,
Yu Jin Ho,
Shim Kye Shik,
Kwon EunMi,
Koh Young Yull
Publication year - 2013
Publication title -
pediatrics international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.49
H-Index - 63
eISSN - 1442-200X
pISSN - 1328-8067
DOI - 10.1111/ped.12125
Subject(s) - medicine , respiratory tract infections , upper respiratory tract infection , respiratory tract , high fever , respiratory system
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 J anuary 2008 to M ay 2009 presenting at one of five tertiary care centers in S eoul, K orea 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. Conclusion Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.