Analgesic efficacy of liquid ketoprofen compared to liquid dipyrone and placebo administered orally as drops in postepisiotomy pain

Objective: The objective of this single-center, single-dose, double-blind r andomized parallel group study was to evaluate the analgesic efficacy of a new liquid formulation of ketoprofen at two dose levels (25 mg or 50 mg) co mpared to a commercially avail able Liquid form of dipyrone 500 mg and plac ebo with all treatments administered as drops to patients with severe poste pisiotomy pain. Methods: The study was designed with a sample size of 69 pa tients per treatment for a total of 276 patients. However, due to administr ative changes at the site, the study was prematurely terminated; thus only 108 patients (26 to 28 patients per treatment), 18 years or older, with sev ere postepisiotomy pain were randomized to one of the four treatments. Trea tments were assessed over a 6-hour period using standard scales for pain in tensity and pain relief and a number of derived variables based on these da ta. Since the study medications were not identical in appearance, the prepa ration and administration of the study medication, and the observation of t he patient, were carried out by two different individuals to maintain doubl e-blind conditions. Results: All active treatments were significantly super ior to placebo for several measures of analgesia including 4-hour and 6-hou r SPID and TOTPAR scores. The global rating was assessed as "good" or "exce llent" by over 75% of the patients in the active treatment groups compared to 7.4% of the patients in the placebo group. Reduction in pain intensity w as very similar for the two-dose levels of ketoprofen and the comparator di pyrone 500 mg. Conclusion: Ketoprofen 25 mg or 50 mg, and dipyrone 500 mg s eem to be equally suited for use as pain relief medication after minor surg ery, as well as episiotomy. This study did not demonstrate a need for more than 25 mg of ketoprofen in postepisiotomy pain. All treatments were well t olerated. No adverse events were reported.