Dose-Finding Studies of Ketoprofen in the Management of Fever in Children: Report on Two Randomized, Single-Blind, Comparator-Controlled, Single-Dose, Multicentre, Phase II Studies

Author： Kokki Hannu Kokki Merja

Publisher： Adis International

ISSN： 1173-2563

Source： Clinical Drug Investigation, Vol.30, Iss.4, 2010-04, pp. : 251-258

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Abstract

Background Ketoprofen is a highly effective NSAID with antipyretic and analgesic properties for the symptomatic management of pain and fever in both adults and children.Objective To compare three dose levels of ketoprofen with paracetamol (acetaminophen) in the management of fever in children.Methods Two prospective, randomized, single-blind, comparator-controlled, single-dose, multicentre, phase II studies with four parallel groups in each study were conducted in primary-care outpatient clinics. Children aged 6-24 months and 2-6 years presenting with a febrile condition (rectal body temperature ≥39°C) were included in the studies. Patients were treated with either ketoprofen syrup 0.25 mg/kg, 0.5 mg/kg or 1 mg/kg, or paracetamol drinkable solution 15 mg/kg, both administered orally. The primary outcome measure was the maximal reduction in body temperature before re-medication compared with baseline during the 6-hour study period.Results In the ketoprofen groups, the mean maximal temperature decreases in the younger/older age groups were 1.6/1.6°C, 2.0/1.9°C and 1.9/2.2°C with doses of 0.25 mg/kg, 0.5 mg/kg and 1 mg/kg of ketoprofen, respectively, compared with 1.8/1.8°C with paracetamol 15 mg/kg. In the older children, ketoprofen provided antipyretic efficacy in a dose-dependent manner.Conclusion Ketoprofen was found to have a significant antipyretic efficacy in children. The lowest dose of ketoprofen syrup that provided a meaningful antipyretic effect in both groups was 0.5 mg/kg. At this dose the antipyretic efficacy was equal to that of paracetamol 15 mg/kg. Based on these data, a dose of 0.5 mg/kg of ketoprofen was selected for future evaluation in phase III studies in the symptomatic management of fever in children.