The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection.
OBJECTIVE
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.
Yoon
Jong Seo
JS
Department of Paediatrics, College of Medicine, the Catholic University of Korea, Seocho-Gu, Seoul, Korea.
Jeong
Dae-Chul
DC
Oh
Jae-Won
JW
Lee
Keun Young
KY
Lee
Hyun Seung
HS
Koh
Young Yull
YY
Kim
Jin Tack
JT
Kang
Jin Han
JH
Lee
Joon Sung
JS
D000284:Administration, Oral; D000293:Adolescent; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000493:pharmacokinetics*; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; C539402:dexibuprofen; D007052:Ibuprofen