Comparative Efficacy and Safety of Ibuprofen, Acetaminophen, And Naproxen in The Management of Pediatric Fever and Pain
Introduction: Fever and pain are among the most common complaints in pediatric practice, resulting in numerous outpatient and emergency visits each year. Symptomatic management of these conditions improves children’s comfort, reduces parental anxiety, and prevents unnecessary healthcare utilization. Acetaminophen has traditionally been the most frequently used antipyretic and analgesic in children due to its safety, availability, and cost-effectiveness. However, it has a short half-life and lacks anti-inflammatory properties. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), offers combined antipyretic, analgesic, and anti-inflammatory effects, with a longer duration of action. Naproxen, another NSAID, provides sustained pain and inflammation control but is less commonly studied for routine pediatric fever management. While comparative trials exist for acetaminophen versus ibuprofen, few studies have evaluated naproxen alongside these two drugs. This study aimed to compare the efficacy and safety of acetaminophen, ibuprofen, and naproxen in children presenting with fever and associated pain. Materials and Methods: A prospective, randomized, open-label, parallel-group trial was conducted in children aged 6 months to 12 years with fever (>38°C) and mild-to-moderate pain. A total of 210 children were randomized into three groups of 70 each: Group A received acetaminophen 15 mg/kg every 6 hours, Group B received ibuprofen 10 mg/kg every 6–8 hours, and Group C received naproxen 5 mg/kg every 12 hours. Baseline demographic data, clinical history, body temperature, and pain scores were recorded. Body temperature was measured hourly for the first 6 hours and then at 12 and 24 hours. Pain was assessed at baseline, 1, 4, 8, and 24 hours using the FLACC scale for younger children and the Wong-Baker Faces Pain Rating Scale for older children. The primary outcome was the mean reduction in body temperature at 4 hours post-drug administration. Secondary outcomes included pain score reduction, duration of fever relief, and adverse effects. Data were analysed using ANOVA and Chi-square tests, with p < 0.05 considered statistically significant. Results: The mean age of participants was similar across groups (acetaminophen 5.9 ± 2.8 years, ibuprofen 6.1 ± 2.6 years, naproxen 6.0 ± 2.9 years; p = 0.82), and gender distribution was comparable (p = 0.91). Baseline fever and associated symptoms were evenly distributed among groups. At 1 hour, mean temperature reduction was 0.6 ± 0.2°C for acetaminophen, 0.8 ± 0.2°C for ibuprofen, and 0.7 ± 0.2°C for naproxen (p = 0.09). At 4 hours, ibuprofen showed a significantly greater temperature reduction (1.6 ± 0.3°C) compared to acetaminophen (1.2 ± 0.3°C) and naproxen (1.5 ± 0.3°C) (p = 0.001). Pain scores decreased more rapidly with ibuprofen (1.8 ± 0.5 at 1 hour, 3.1 ± 0.8 at 4 hours) than with acetaminophen (1.4 ± 0.6 at 1 hour, 2.5 ± 0.7 at 4 hours) and naproxen (1.7 ± 0.6 at 1 hour, 3.0 ± 0.7 at 4 hours), with significant differences at 1, 4, and 8 hours (p < 0.05). Adverse effects were mild and comparable, although naproxen showed a slightly higher incidence of gastrointestinal discomfort. Conclusion: Ibuprofen provides more rapid relief of fever and pain in children compared to acetaminophen and naproxen, particularly within the first 8 hours of treatment. After 24 hours, all three drugs are similarly effective. Naproxen is effective but may cause more stomach-related side effects. Ibuprofen is recommended as the first-line choice for fast symptom relief, acetaminophen remains a safe alternative, and naproxen may be reserved for situations requiring longer dosing intervals with caution in younger children.