A RANDOMIZED, DOUBLE-BLIND-STUDY OF THE EFFICACY AND SAFETY OF MICROCAPSULATED BUTIBUFEN AND NAPROXEN IN THE TREATMENT OF POST-EPISIOTOMY PAIN

A randomized, double-blind study was performed to compare the clinical efficacy and safety of microcapsulated butibufen and naproxen, two no nsteroidal anti-inflammatory (NSAID) drugs, in post-episiotomy pain, S ixty postpartum patients with right midlateral episiotomy were include d in this study, After the anesthesic effect of lidocaine wore off (30 to 120 minutes postpartum), the NSAIDs were administered at a dosage of 500 mg every 12 hours for 3 days, Analgesic and anti-inflammatory a ctivities were periodically assessed, both by the physician and the pa tient, 6 hours after NSAID administration, The analgesic activity of t he drugs was measured according to a four-point scale, Edema, hyperemi a, and suture dehiscence were evaluated in assessing improvement in th e inflammatory response, Furthermore, the clinical efficacy and tolera bility were assessed daily, Both therapeutic agents were effective in relieving painful symptoms, with statistically significant differences between the beginning and the end of treatment (P < 0.001). Microcaps ulated butibufen provided faster relief of pain with significant diffe rences from baseline scores after 24 hours (P < 0.05), There were no s ignificant differences (P < 0.001) in the naproxen-treated group until 48 hours after baseline measurement, The anti-inflammatory response w as also favorable for microcapsulated butibufen, obtaining higher stat istical differences between the beginning and the end of treatment (P < 0.001 for microcapsulated butibufen and P < 0.01 for naproxen), The physician evaluated the treatment with butibufen as excellent or good in 86.7% of patients and appeared favorably disposed to its future use in 96.7%; with naproxen, these values were 73.3% and 86.7%, respectiv ely, The patients' final evaluations were similar in all cases. Tolera nce was excellent in both groups, The only side effect reported was on e case of mild cutaneous rash in the group treated with microcapsulate d butibufen.