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

• Published in: Pediatrics (Evanston) 1997-12, Vol.100 (6), p.954-957
• Main Authors: Lesko, Samuel M, Mitchell, Allen A
• Format: Article
• Language: English
• Subjects: Acetaminophen - pharmacology; Acetaminophen - therapeutic use; Analgesics, Non-Narcotic - pharmacology; Analgesics, Non-Narcotic - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - pharmacology; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Biological and medical sciences; Blood Urea Nitrogen; Child; Child, Preschool; Children & youth; Complications and side effects; Creatinine; Creatinine - blood; Double-Blind Method; Drug toxicity and drugs side effects treatment; Female; Fever - drug therapy; Humans; Ibuprofen; Ibuprofen - pharmacology; Ibuprofen - therapeutic use; Infant; Kidney; Kidney - drug effects; Kidney - physiology; Kidney diseases; Kidney Diseases - blood; Kidney Diseases - chemically induced; Kidneys; Male; Measurement; Medical disorders; Medical sciences; Pediatrics; Pharmaceuticals; Pharmacology. Drug treatments; Risk factors; Toxicity: urogenital system
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.100.6.954

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.