Abstract
The Children’s Analgesic Medicine Project (CAMP) was a multicenter, all-comers, openlabel, prospective study to compare the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. Four hundred and twenty four (424) pediatricians enrolled 41 810 children (aged 1 month to 18 years old) at 69 US clinics. Safety data included information concerning medication use and adverse events (AEs) summarized by severity and analyzed by age groups (younger and older than 2 years). Among 30 144 children who took at least one dose of ibuprofen or acetaminophen, 14 281 were younger (< 2 yrs) and 15 863 were older (⩾ 2 to < 12 yrs). Within both age groups, the incidence rates for specific AEs, including abdominal pain, insomnia, and hyperkinesia were rare and generally < 1% for both treatments. For younger children, fever, vomiting, diarrhea, rhinitis, rash and otitis media were the only AEs with an incidence rate > 1% (in either treatment group). For older children, the only AEs with an incidence rate > 1% in either group were rhinitis, pharyngitis and otitis media. AEs were generally mild to moderate for both treatments within the two age groups. There were no serious AEs, including anaphylaxis, Reye’s syndrome, renal failure, GI bleeding/perforation or necrotizing fasciitis. There was a slightly higher overall incidence of side effects in the ibuprofen group (17.6% vs. 15.0%) for the younger children; and similar results were seen in the older children (11.9% vs. 10.7%). This may have been due to the preference of physicians to treat the sicker children with ibuprofen. There were four deaths, all unrelated to study medication, all occurring in children < 2 yrs (herpes encephalitis, sepsis due to 5. pneumoniae, medulloblastoma, and sudden infant death syndrome). The safety of ibuprofen suspension in children < 2 yrs was demonstrated in this study. The safety profile in children < 2 yrs is consistent with the excellent profile observed in children ⩾ 2 yrs. Overall, ibuprofen exhibited an AE profile similar to acetaminophen in both younger and older children.
Similar content being viewed by others
References
Czaykowski, D., Fratarcangelo P. and Rosefsky, J. (1994). Evaluation of the antipyretic efficacy of single dose ibuprofen suspension compared to acetaminophen elixir in febrile children, Pediatr. Res. 35, 141 A.
Diez-Domingo, J., Planelles, M. V., Baldo, J. M., Ballester, A., Nunez, F., Jubert, A. and Dominguez-Granados, R. (1998). Ibuprofen prophylaxis for adverse reactions to diphtheria-tetanus-pertussis vaccination: a randomized trial, Curr. Ther. Res. 59, 579–588.
Lesko, S. M. and Mitchell, A. A. (1995). An assessment of the safety of pediatric ibuprofen. A practitioner-based randomized clinical trial, JAMA 273, 929–933.
Rainsford, K. D., Roberts, S. C. and Brown, S. (1997). Ibuprofen and paracetamol: relative safety in nonprescription doses, J. Pharm. Pharmacol. 49, 345–376.
Walson, P., Galletta, G., Braden, N. J. and Alexander, L. (1989). Ibuprofen, acetaminophen, and placebo treatment of febrile children, Clin. Pharmacol. 46, 9–17.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Ashraf, E., Ford, L., Geetha, R. et al. Safety profile of ibuprofen suspension in young children. Inflammopharmacol 7, 219–225 (1999). https://doi.org/10.1007/s10787-999-0005-0
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/s10787-999-0005-0