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 nonsteroidal anti-inflammatory (NSAID) drugs, in post-episiotomy pain, Sixty postpartum patients with right midlateral episiotomy were included 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 activities were periodically assessed, both by the physician and the patient, 6 hours after NSAID administration, The analgesic activity of the drugs was measured according to a four-point scale, Edema, hyperemia, and suture dehiscence were evaluated in assessing improvement in the inflammatory response, Furthermore, the clinical efficacy and tolerability 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). Microcapsulated butibufen provided faster relief of pain with significant differences from baseline scores after 24 hours (P < 0.05), There were no significant differences (P < 0.001) in the naproxen-treated group until 48 hours after baseline measurement, The anti-inflammatory response was also favorable for microcapsulated butibufen, obtaining higher statistical 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%, respectively, The patients' final evaluations were similar in all cases. Tolerance was excellent in both groups, The only side effect reported was one case of mild cutaneous rash in the group treated with microcapsulated butibufen.