Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma

Abstract

BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.)

Individualized therapy for persistent asthma in young children

“…Details of that study were previously published. 20 Children were randomized in two processes: the first determined the crossover sequence of asthma therapy and the second determined the blinded antipyretic/analgesic medication to be used as needed for fever or pain throughout the 48 week duration of the crossover study, with stratification by clinical center.…”

Rotenone Protects Against Acetaminophen-Induced Kidney Injury by Attenuating Oxidative Stress and Inflammation

“…Acetaminophen (APAP), an analgesic and antipyretic agent, is better known as paracetamol in many countries. APAP is used in adults and children worldwide with a safety profile in therapeutic doses [4][5][6]. However, excessive APAP can cause severe hepatotoxicity, nephrotoxicity, and even death in experimental animals and humans [7].…”

Safety Issues of Pharmacological Acute Pain Treatment in Children

“…Studies have suggested an association between acetaminophen and the development or exacerbation of asthma 44 and alteration of immune response in children. 45,46 Findings are, however, conflicting and several confounding factors (treatment indication and concomitant viral respiratory infection) might contribute to this positive correlation.…”