[Evaluation of the antipyretic safety and accuracy of two pediatric ibuprofen formulations].

Abstract

AIM:

To compare the efficacy and to evaluate the clinical bioequivalence of two different formulations of ibuprofen (suspension and effervescent granules) in febrile children.

METHODS:

An open, randomized, multicenter study. Febrile children (axillary temperature 38 degrees C) weighing more than 25 kg, admitted into the emergency departments of the participating hospitals were randomly assigned to either of the two treatment groups: ibuprofen suspension (7 mg/kg) or effervescent granules at the following dosages: 200 mg in children weighing 2540 kg or 400mg in children weighing 3540 kg and with an axillary temperature above 39 degrees C. This latter dose of 400 mg was also given to children weighing more than 40 kg.The investigators took axillary temperature before treatment and 30, 60, 90, 120, 180 and 240 min after administration of the corresponding dose. Possible adverse events were noted.

RESULTS:

A total of 103 patients were included in the study; 51 received the effervescent granules and 52 received the suspension formulation. The mean temperature was reduced in both groups during the study (p < 0.005). No differences were found between the formulations. The mean differences of temperatures at each point of the study were within the clinical bioequivalence interval (+/-0.5 degrees C). Only one patient had an axillary temperature of 35.9 degrees C. This was the only adverse event recorded in the study.

CONCLUSIONS:

Both ibuprofen formulations were effective in reducing fever and may be considered clinically bioequivalent.

• Authors: J Díez Domingo, M V Planelles Cantarino, F Moreno Madrid, J Uberos Fernández, J Moreno Martín, A Molina Carballo, J Antelo Cortizas, S Armenteros González, R Domínguez Granados, E Moreno Carretero
• Journal: Anales espanoles de pediatria (An Esp Pediatr) Vol. 53 Issue 5 Pg. 436-40 (Nov 2000) ISSN: 0302-4342 [Print] Spain
• Vernacular Title: Evaluación de la eficacia antipirética yseguridad de dos formulaciones pediátricas de ibuprofeno.
• PMID: 11141365 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Non-Narcotic
• Anti-Inflammatory Agents, Non-Steroidal
• Suspensions
• Ibuprofen

Topics

• Adolescent
• Analgesics, Non-Narcotic (administration & dosage, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Body Temperature
• Body Weight
• Chemistry, Pharmaceutical
• Child, Preschool
• Data Interpretation, Statistical
• Female
• Fever (diagnosis, drug therapy)
• Humans
• Ibuprofen (administration & dosage, therapeutic use)
• Male
• Suspensions
• Therapeutic Equivalency