Renal function after short-term ibuprofen use in infants and children

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

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.

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 micromol/L, respectively. The prevalence of a creatinine level >62 micromol/L was 9.5% overall and did not vary by antipyretic assignment. Among 83 children hospitalized with dehydration, the mean creatinine level was 44 micromol/L, and the prevalence of an elevated creatinine was 14%; neither measure varied by antipyretic assignment.

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.