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.

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 > or =39 degrees 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 degrees C, 2.0/1.9 degrees C and 1.9/2.2 degrees 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 degrees 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.