Abstract
INTRODUCTION: When a child presents with fever in the clinical encounter, parents are usually concerned about alleviating the fever. However, the indications for selecting an appropriate drug from the most commonly used antipyretic drugs, acetaminophen and ibuprofen, remain unclear. The purpose of this study was to assess the efficacy and safety of acetaminophen and ibuprofen in febrile children through a systematic review with meta-analysis of randomized controlled trials (RCTs). MATERIAL AND METHODS: Cochrane, Embase, and PubMed databases were searched for the relevant RCTs. Two authors individually extracted information on trial design, demography, rate of fever resolution, body temperature, and overall adverse events. Data were pooled mainly using a random-effects model; however, because of some sparse data, Peto odds ratios (PORs) were used for outcomes of fever resolution and adverse event. 95% confidence intervals (CIs) were also presented. RESULTS: In total, 26 RCTs (n = 4137) fulfilled eligibility criteria. Pooled estimates demonstrated that acetaminophen led to significantly lower fever resolution rates than ibuprofen did (POR = 0.91, 95% CI: 0.84-0.98; I (2) = 0%) in the subgroup of trials with a mean age of < 2 years. However, the treatment-time interaction model for body temperature demonstrated that the fever resolution effect was mainly from the time factor based on the available data (effect size = -0.20; 95% CI: -0.30 to -0.11; I (2) = 6.9%). Acetaminophen demonstrated lower overall adverse event rates than ibuprofen (POR = 0.71; 95% CI: 0.58-0.87; I (2) = 0%). CONCLUSIONS: The effects of ibuprofen are similar to acetaminophen even in children with mean age of approximately 5 years. Nevertheless, acetaminophen is safer than ibuprofen, particularly in children approximately 5 years old.