Study Objective: To obtain additional information on efficacy and safety of the use of a fixed combination of Paracetamol and Ibuprofen in children with fever associated with acute respiratory tract infection (ARTI). Study Design: Multicentre open-label cohort observational study. Materials and Methods. 242 children aged 3 to 12 years old (mean age: 6.3 ± 2.7 years old) with ARTI and fever participated in the study. When the body temperature was 38.1°С and higher, we used an antipyretic combination: a dispersible tablet containing 100mg Ibuprofen and 125mg Paracetamol (Ibuclin Junior®), 1 tablet 3 times daily in children aged 3 to 6 years old, and up to 6 tablets in children aged 7 to 12 years old (max. for 4 days). We evaluated the clinical efficacy and safety of the antipyretic therapy, parents’ satisfaction (using the Integrative Medicine Patient Satisfaction Scale), and quality of child’s life (sleep, appetite, play activity). Study Results. During examination, mean body temperature was 38.8°С (mostly 38.6 to 39.0°С). On day 1, 2, 3, and 4, antipyretic therapy was needed by 242 (100%), 168 (69.4%), 65 (26.9%), and 2 (0.8%) children, respectively. During first two days, patients took on an average 2 tablets, then 1 tablet. After the first dose, the normal body temperature (< 37.2°C) in 1, 4, 24, 48, and 72 hours was observed in 14%, 62%, 43.4%, 71.5%, and 98% of patients; while the mean body temperature was 37.6; 37.1; 37.6; 37.0, and 36.5°С, respectively. No adverse events or therapy failures were recorded during the study. In 48 and 72 hours after initiation of therapy, a share of parents who were “completely satisfied” and “satisfied” with the medicinal product was 86,4% and 95,9%, respectively. Poor quality of child’s life correlated with severity of fever; in 96 hours after therapy initiation, sleep and play activity normalised in over 90% of patients, appetite got better in 77%. Conclusion. Study results demonstrate high efficacy (even after the first dose) and safety of a combination product (dispersible tablets containing Ibuprofen and Paracetamol) for the management of fever in children with ARTI; and the product can be recommended for wide use in paediatrics. Keywords: children, acute respiratory tract infections, fever, Paracetamol, Ibuprofen.
Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections
