Elsevier

The Journal of Pediatrics

Volume 131, Issue 5, November 1997, Pages 683-687
The Journal of Pediatrics

Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children,☆☆,

https://doi.org/10.1016/S0022-3476(97)70093-3Get rights and content

Abstract

The antipyretic activity of ibuprofen in the Sparklets form was compared, in an equivalence study, with that of paracetamol in the same formulation. The study was conducted as a double-blind multicenter trial, with random allocation of the treatments. One hundred sixteen children of both sexes, aged 4.1 ± 2.6 years, with a fever related to an infectious disease and a mean temperature of 39° ± 0.5° C at the time of inclusion, were treated with single doses of either 10.3 ± 1.9 mg/kg of ibuprofen or 9.8 ± 1.9 mg/kg of paracetamol. The subjects’ rectal temperature was regularly monitored for 6 hours. The statistical analysis of the results confirmed that ibuprofen and paracetamol are equivalent with respect to the following criteria (1) time elapsed between dosing and the lowest temperature: 3.61 ± 1.34 hours for ibuprofen and 3.65 ± 1.47 hours for paracetamol (95% confidence interval [CI] of the difference: –0.48; +0.56); (2) extent of the temperature decrease: 1.65° C ± 0.80° C for ibuprofen and 1.50° C ± 0.61° C for paracetamol, (95% CI of the difference: –0.41; +0.11); (3) rate of temperature decrease: 0.52 ± 0.32° C/hr for ibuprofen and 0.51° C ± 0.38° C/hr for paracetamol (95% CI of the difference: –0.45; +0.55); (4) duration of temperature below 38.5° C: 3.79 ± 1.33 hours for ibuprofen and 3.84 ± 1.22 hours for paracetamol (95% CI of the difference: –0.14; +0.12). (J Pediatr 1997;131:683-7)

Section snippets

Methods

The study was approved by the local ethics committee and was conducted in accordance with the European Good Clinical Practice standards (1989) and the Declaration of Helsinki and subsequent amendments.

Results

No significant difference was found for the two treatment groups (Table I) with respect to age, weight, height, sex, dosage relative to body weight, or rectal temperature at the time of inclusion in the study. For 2 of the 116 assessable patients, the main parameter was missing. Therefore these patients, who belonged to the ibuprofen group, could not be taken into account in the analysis of equivalence.

The rectal temperatures (θ°) of the two treatment groups at the different evaluation times

Discussion

The intention-to-treat analysis showed equivalence between 10 mg/kg ibuprofen and 10 mg/kg paracetamol, with both drugs administered as Sparklets, with respect to the time elapsed between dosing and the lowest observed temperature (T max ) within 6 hours. On the basis of the calculated 95% CI, the difference between the two treatment groups could at most have been equal to 0.56 hour. This equivalence also applied to the extent and to the rate of temperature decrease in the two groups. The lack

Acknowledgements

We gratefully acknowledge all the physicians who recruited the patients for the study (Drs. G. Almodovar, A. Assouline, J. Azoulay, M. Behar, N. Castaing, J. Castel, B. Cohen, J. Fridman, P. Grandsenne, A. Meyer, F. Moureau, J. Rebot, F. Richoux, J. Sultan, and L. Van).

References (12)

  • JT Wilson et al.

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

    J Pediatr

    (1991)
  • M Gex-Fabry et al.

    Considerations on data analysis using computer methods and currently available software for personal computers

  • PD Walson et al.

    Ibuprofen, paracetamol and placebo treatment of febrile children

    Clin Pharmacol Ther

    (1989)
  • VK Sheth et al.

    Measurement of antipyretic activity of ibuprofen and paracetamol in children

    J Clin Pharmacol

    (1980)
  • S Simila et al.

    Oral antipyretic therapy. Evaluation of ibuprofen

    Scand J Rheumatol

    (1976)
  • YK Amdekar et al.

    Antipyretic activity of ibuprofen and paracetamol in children with pyrexia

    Br J Clin Pract

    (1985)
There are more references available in the full text version of this article.

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Sponsored by the Laboratories Ethypharm, Houdan, France.

☆☆

Reprint requests: Gérard Pons, MD, PhD, Pharmacologie Clinique Périnatale et Pédiatrique, Hôpital Saint-Vincent de Paul, 82, Avenue Denfert Rochereau, 75674 Paris Cédex 14, France.

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