Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections

Eur J Clin Pharmacol. 1999 Nov;55(9):615-8. doi: 10.1007/s002280050681.


Objective: The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs).

Methods: Ninety children with acute URTIs and fever were enrolled to the study. The patients were allocated to three groups. The first group was treated with paracetamol 10 mg/kg thrice daily; the second group with ibuprofen 10 mg/kg thrice daily; and the third group received nimesulide 2.5 mg/kg twice daily for 5 days.

Results: The anti-pyretic activity of nimesulide was greater and more rapid than either paracetamol or ibuprofen. The number of patients with normal temperature was significantly greater in the first 2 days for the nimesulide group. The improvement in cough for the paracetamol group was better than the others.

Conclusion: The results of this study demonstrated that the anti-pyretic effectiveness of nimesulide is better than paracetamol and ibuprofen in febrile children with URTIs. However, new studies in larger paediatric populations are required to explore the anti-inflammatory effect of nimesulide.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / therapeutic use*
  • Acute Disease
  • Adolescent
  • Analgesics, Non-Narcotic / therapeutic use*
  • Analysis of Variance
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Body Temperature
  • Child
  • Child, Preschool
  • Female
  • Fever / drug therapy*
  • Humans
  • Ibuprofen / therapeutic use*
  • Male
  • Respiratory Tract Infections / drug therapy*
  • Sulfonamides / therapeutic use*
  • Treatment Outcome


  • Analgesics, Non-Narcotic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Sulfonamides
  • Acetaminophen
  • nimesulide
  • Ibuprofen