The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection

Abstract

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.

Figure 1

Changes of mean temperature (°C) after the administration of 5 mg kg⁻¹ dexibuprofen, 7 mg kg⁻¹ dexibuprofen, and 10 mg kg⁻¹ ibuprofen, respectively. No significant differences were observed among the groups at any time point (P > 0.05). Dexibuprofen 5 mg/kg (); Dexibuprofen 7 mg/kg (); Ibuprofen 10 mg/kg ()