The efficacy of ibuprofen was better than that of aspirin or paracetamol. In spite of more adverse events, the comfort scores were significantly in favour of ibuprofen 6 h after the first dose of treatment.
The pharmacokinetic parameters of paracetamol were studied
after 15 min intravenous infusion of 15 mg/kg of propacetamol
(Prodafalgan®) in 5 neonates aged less than 10 days and 7
infants aged between 1 and 12 months. Blood was sampled at
0,0.5,2 and 6 h after the first intravenous infusion of propacetamol.
The infants aged less than 10 days had higher plasma
concentrations of paracetamol, a longer half-life (3.5 vs. 2.1 h)
and a lower plasma clearance (0.149 vs. 0.365 l/h/kg) than the
older children. Dose simulations were performed on the basis
of individual data of each child in order to obtain steady-state
plasma concentrations between 4 and 18 mg/1 permitting the
best antipyretic effect for each child. In infants aged less than
10 days a 15 mg/kg dose of propacetamol four times a day (i.e.
30 mg/kg/day paracetamol) is sufficient, corresponding to the
dosage recommended by the French pharmacopoeia. On the
other hand, double the dosage, nearer to the American dosage,
is necessary for children aged over 10 days.
A double-blind, randomised, parallel group study has been done comparing the efficacy and tolerability of 7.5 mg/kg ibuprofen syrup (n = 77) and 10 mg.kg-1 acetaminophen syrup (n = 77) in 154 children (6 months to 5 years) with fever (> or = 38 degrees C) associated with infectious diseases and treated with antibiotic therapy. The area under the percentage reduction in temperature curve captured the net effect of each drug and provided the best estimate for comparison of efficacy during a defined period. Temperature evolution over time was not significantly different between the two groups. Nevertheless, the temperature reduction over the first 4 h of treatment (H0-H4) was significantly higher after ibuprofen (60%) than acetaminophen (45%). Both ibuprofen and acetaminophen were well tolerated. In conclusion, significant antipyretic activity, good tolerability and its availability as a syrup make ibuprofen an effective means of fever control in children.
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