An Observational Study on the Safety and Effectiveness of Mefenamic Acid in Paediatric Patients with Febrile Illness: Real World Evidence in Indian Paediatric Settings (ASSESS-MAPP)

This prospective multicentre observational study is designed to evaluate the effectiveness and tolerability of mefenamic acid in paediatric outpatient settings. A total of 150 practicing paediatricians each qualified with MBBS and MD Paediatrics DNB Paediatrics or DCH will participate in the study. These 150 paediatricians will enroll 10 patients each at their outpatient department, resulting in a total of 1500 paediatric patients. Eligible participants will be children aged between six months and twelve years presenting with fever greater than 99.5 degree F managed on an outpatient basis with mefenamic acid. Digital informed consent will be obtained from the parent or legally acceptable representative prior to any data collection to ensure ethical compliance.

Effectiveness will be assessed by calculating the area under the curve of the percent reduction in fever from baseline across multiple time points, including 0 minutes 15 minutes 30 minutes 45 minutes 1 hour 2 hours 4 hours 6 hours and 8 hours. In addition the treating paediatrician’s clinical judgment will be used to evaluate both effectiveness and tolerability. All adverse events observed during the study will be carefully documented in electronic case report forms capturing details such as the nature severity duration and any medical or procedural actions taken. This structured approach aims to provide comprehensive insights into the clinical utility and safety profile of mefenamic acid in routine paediatric practice