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PEDIATRICS Vol. 100 No. 6 December 1997, pp. 954-957

Renal Function After Short-term Ibuprofen Use in Infants and Children

Received Mar 25, 1997; accepted May 12, 1997.

Samuel M. Lesko and Allen A. Mitchell

From the Slone Epidemiology Unit, School of Public Health, Boston University School of Medicine, Brookline, Massachusetts.

Objective.  To test the hypothesis that short-term use of ibuprofen increases the risk of impaired renal function in children.

Study Design.  Randomized, double-blind acetaminophen-controlled clinical trial. Children with a febrile illness were enrolled from outpatient pediatric and family medicine practices and randomly assigned to receive either acetaminophen suspension or one of two dosages of ibuprofen suspension (5 mg/kg or 10 mg/kg) for fever control.

Results.  Mean blood urea nitrogen levels on admission among children admitted to hospital and assigned ibuprofen 5 mg/kg (n = 96), ibuprofen 10 mg/kg (n = 102), and acetaminophen 12 mg/kg (n = 87) were 4.1, 3.8, and 3.9 mmol/L, respectively. The corresponding creatinine levels were 43, 41, and 43 µmol/L, respectively. The prevalence of a creatinine level >62 µmol/L was 9.5% overall and did not vary by antipyretic assignment. Among 83 children hospitalized with dehydration, the mean creatinine level was 44 µmol/L, and the prevalence of an elevated creatinine was 14%; neither measure varied by antipyretic assignment.

Conclusion.  Although renal failure in children has been reported after ibuprofen use, these data suggest that for short-term use the risk of less severe renal impairment, as reflected by blood urea nitrogen and creatinine levels, is small and not significantly greater than that after acetaminophen use.

Key words: ibuprofen, nonsteroidal antiinflammatory drugs, acetaminophen, renal function, blood urea nitrogen, creatinine, clinical trial.




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