Effectiveness and Safety of Mefenamic Acid Oral Suspension in Pediatric Practice for Febrile Illness: An Observational Study (EASE-O-MAPP Study)

Introduction Fever and associated pain are among the most common pediatric symptoms. If not managed promptly, they can lead to discomfort, irritability, and reduced well-being in the child, as well as increased anxiety among caregivers. Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits antipyretic, analgesic, and anti-inflammatory properties, making it a suitable option for symptomatic management. Pediatric oral suspension allows for weight-based dosing and convenient administration of mefenamic acid in children. This study aims to evaluate the real-world effectiveness and safety of mefenamic acid oral suspension in the treatment of fever and associated symptoms in pediatric patients. Methods This single-center, prospective, open-label, investigator-initiated, observational study was conducted between December 30, 2024, and April 4, 2025. The study included 50 pediatric subjects (six months to <18 years) with fever (>99.5°F). Mefenamic acid oral suspension was administered at a dose of 5 mg/kg three times daily for up to three days, or until normothermia was achieved, whichever occurred earlier. Efficacy was evaluated based on the degree of fever reduction and the time required to achieve sustained normothermia. Safety assessment included laboratory and clinical evaluations, such as blood tests, urinalysis, fecal occult blood testing (FOBT), completion of a gastrointestinal (GI) symptom questionnaire, and monitoring for adverse events. Results A total of 50 participants completed the study. The major causes of fever were upper respiratory tract infection (72%) and lower respiratory tract infection (24%). A significant decrease in mean body temperature was observed from baseline (102.36 ± 0.78°F) to the end of treatment on day 3 (98.61 ± 0.69°F; p < 0.0001). The mean time to achieve normothermia after the first dose was 1.99 ± 0.47 hours, while sustained normothermia was maintained for an average of 61.92 ± 11.52 hours. No treatment-related adverse events or clinically significant laboratory abnormalities were observed during the study period. Conclusion Mefenamic acid oral suspension demonstrates a rapid and sustained antipyretic effect in pediatric patients, producing significant temperature reduction without affecting hematological or biochemical parameters. These findings confirm its efficacy, safety, and good GI tolerability in the management of febrile illnesses among children.