Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children☆,☆☆,★
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)
- et al.
Single-dose, placebo-controlled comparative study of ibuprofen and acetaminophen antipyresis in children
J Pediatr
(1991) - et al.
Considerations on data analysis using computer methods and currently available software for personal computers
- et al.
Ibuprofen, paracetamol and placebo treatment of febrile children
Clin Pharmacol Ther
(1989) - et al.
Measurement of antipyretic activity of ibuprofen and paracetamol in children
J Clin Pharmacol
(1980) - et al.
Oral antipyretic therapy. Evaluation of ibuprofen
Scand J Rheumatol
(1976) - et al.
Antipyretic activity of ibuprofen and paracetamol in children with pyrexia
Br J Clin Pract
(1985)
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Sponsored by the Laboratories Ethypharm, Houdan, France.
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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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