RESUMO
The aim was to assess and document the efficacy and tolerability of parflex (FDC of aceclofenac with paracetamol and serratiopeptidase) in management of pain and inflammation in adult patients undergoing surgical procedures (or operations). The design was open, prospective, non-comparative and multi-dose study of patients undergoing surgical procedures at a leading, tertiary-care, teaching hospital (setting) in Lucknow, the name being, King George's Medical College, Lucknow 226003. The patients were 50 adult patients of either sex undergoing surgery. They were given 1 tablet twice daily, taken after meals. Treatment duration was for a total of up to 7 days (intervention). Primary efficacy variables were relief from postoperative pain. Secondary efficacy variables were global assessment of efficacy and toleration by patients and treating physicians. Record was made of spontaneously reported adverse events with their nature, intensity and outcome (tolerability). Out of 50 patients, 31% were (ENT), 36% were (Orthopaedic) and 33% were (Gynaecology). They were enroled in this study. The observations made were mean pain score showed significant improvement with study drug - decreasing from 2.66 at baseline to 1.36 after 48 hours, and to 0.8 at the end of study. Composite score for pain, fever and swelling also showed substantial gains visit-on- visit-decreasing from 3.62 at baseline to 2.04 after 48 hours, and to 0.98 at final visit. None of the patients reported any adverse event. Global efficacy assessment was rated as 'excellent or good' by 54% of patients and in 59% of patients by their treating physicians. To conclude, parflex is an effective analgesic, anti-inflammatory drug that has a valuable therapeutic option for controlling pain and inflammation after surgical procedures.