Home> Uses of Ibuprofen: Fever > Summary of clinical trials

1. Evaluation of the antipyretic efficacy of single dose ibuprofen suspension compared to acetaminophen elixir in febrile children

Study design
A randomised double-blind, parallel, single-dose study in 113 children comparing the antipyretic efficacy of ibuprofen suspension (5 & 10 mg/kg) and paracetamol (10-15 mg/kg).

This study was:
randomised
double-blind

Summary of results
Fever decreased more rapidly in the ibuprofen group and the maximum temperature decrease was greater for ibuprofen than for paracetamol for temperatures >102.5 °F

Reference
Czaykowski D et al. Evaluation of the antipyretic efficacy of single dose ibuprofen suspension compared to acetaminophen elixir in febrile children. Paediatric Research, April 1994;Vol 35 (4) Part2, Abstr.829

2. Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children

Study design
Single doses of ibuprofen syrup 6 mg/kg and paracetamol syrup 10 - 15 mg/kg were compared in 36 children (age 0.9 - 11.4 years) with fever (mean 102.7°F)

This study was:
randomised

Summary of results
Ibuprofen was more effective than paracetamol at lowering temperature at 4, 5, 6, 7 and 8 hours after dosing. Adverse effects were not reported in this study. Note that the dose of ibuprofen used in this study is less than the marketed, recommended dose.

Reference
Kelley MT et al. Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children. Clin Pharmacol Ther 1992;52:181-9

3. Evaluation of sponging and antipyretic medication to reduce body temperature in febrile children

Study design
Single doses of ibuprofen 8 mg/kg and paracetamol 15 mg/kg were compared with sponging in 151 children (mean age 22 - 28 months) with fever >39°C.

This study was:
randomised

Summary of results
All treatments significantly reduced temperature. Sponging was significantly more effective at 30 minutes but did not reduce temperature further. Both ibuprofen and paracetamol were more effective at 1 hour and after, with maximum effect at 3 hours. The rate of temperature reduction was greater with ibuprofen than paracetamol, becoming statistically significant after 3 hours. No serious adverse effects were reported.

Reference
Aksoylar S et al. Evaluation of sponging and antipyretic medication to reduce body temperature in febrile children. Acta Paed Jap 1997;39:215-7

4. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children

Study design
Ibuprofen syrup (2.5, 5 or 10 mg/kg) and paracetamol elixir (15 mg/kg) every 6 hours for 24 - 48 hours were compared in 61 evaluable children (age 0.5 - 11.6 years) with fever (39.0 - 40.1°C).

This study was:
randomised
double-blind

Summary of results
Temperature reduction after 6 hours was significantly greater with ibuprofen 10 mg/kg and paracetamol; there were no significant differences between ibuprofen 10 mg/kg and paracetamol. All treatments were well tolerated, with most reported adverse events attributable to fever rather than the treatment.

Reference
Walson PD et al. Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. Am J Dis Child 1992;146:626-32

5. Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics

Study design
Ibuprofen (7.5 mg/kg) and paracetamol (10 mg/kg) were compared in a study of 154 children with fever (rectal temp > or = 38 °C) associated with infectious diseases and treated with antibiotic therapy.

This study was:
randomised

Summary of results
The mean % reduction in temperature at hour 4 was greater with ibuprofen than paracetamol (p=0.04). Additionally, in children who had an initial rectal temperature > or = 39°C (high fever subgroup), ibuprofen provided superior fever reduction shown by area under the % temperature reduction-time curve between hrs 0-4, 0-6 and 0-12 (p=0.046, p=0.020, p=0.020 respectively) and also by mean reduction in temperature (%) at hour 4 (p=0.003) and mean reduction in temperature (°C) between hours 0-4 (p= 0.010)

Reference
Autret E et.al. Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics. Eur J Clin Pharmacol 1997;51:367-71.

6. Anti-pyretic efficacy of ibuprofen vs acetaminophen

Study design
Study comparing antipyretic efficacy of ibuprofen (7.5 or 10 mg/kg), paracetamol (10 mg/kg) and placebo in 37 children aged 2-12 years with a febrile illness.

This study was:
randomised
double-blind

Summary of results
Ibuprofen (10 mg/kg) provided a longer duration of antipyresis than paracetamol (10 mg/kg)
NB No statistics given

Reference
Kauffmann RE et.al. Anti-pyretic efficacy of ibuprofen vs acetaminophen. AJDC.1992; 146:622-625

7. Single-dose placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children

Study design
Ibuprofen 5 or 10 mg/kg and paracetamol 12.5 mg/kg were compared in 178 children with fever.

This study was:
placebo-controlled
double-blind

Summary of results
Time to return of the febrile state (offset time) was significantly longer for ibuprofen 10 mg/kg than paracetamol (although this was difficult to evaluate as only about 50% of patients were available for follow-up after 6 hours).

Reference
Wilson JT et.al. Single-dose placebo controlled comparative study of ibuprofen and acetaminophen antipyresis in children. J Pediatr. 1991; 119: 803-11