S M Lesko1, A A Mitchell. 1. Slone Epidemiology Unit, School of Public Health, Boston University School of Medicine, Brookline, Massachusetts 02146, USA.
Abstract
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 assignedibuprofen 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. 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.
RCT Entities:
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 ureanitrogen 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. 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 ureanitrogen and creatinine levels, is small and not significantly greater than that after acetaminophen use.
Authors: Tess E Cooper; Lauren C Heathcote; Brian Anderson; Marie-Claude Grégoire; Gustaf Ljungman; Christopher Eccleston Journal: Cochrane Database Syst Rev Date: 2017-07-24