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The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection
Author(s) -
Yoon Jong Seo,
Jeong DaeChul,
Oh JaeWon,
Lee Keun Young,
Lee Hyun Seung,
Koh Young Yull,
Kim Jin Tack,
Kang Jin Han,
Lee Joon Sung
Publication year - 2008
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2008.03271.x
Subject(s) - ibuprofen , medicine , antipyretic , upper respiratory tract infection , respiratory tract infections , tolerability , etodolac , anesthesia , population , analgesic , adverse effect , osteoarthritis , respiratory system , pharmacology , environmental health , alternative medicine , pathology
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The analgesic and anti‐inflammatory efficacy of dexibuprofen compared with ibuprofen in adults with osteoarthritis, rheumatoid arthritis and dental pain. WHAT THIS STUDY ADDS • Dexibuprofen is as effective and tolerable as ibuprofen, and a dose of 5 mg kg −1 of dexibuprofen would be sufficient to control fever caused by upper respiratory tract infection in children. AIM 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.