Minerva stomatologica
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Minerva stomatologica · May 1993
Randomized Controlled Trial Comparative Study Clinical Trial[Analgesic efficacy and the tolerance for piroxicam-beta-cyclodextrin compared to piroxicam, paracetamol and placebo in the treatment of postextraction dental pain].
Acute postoperative pain is a common experience in oral surgery practice. Non-steroidal anti-inflammatory drugs (NSAIDs) are quite effective against mild to moderate pain and they are generally better suited in ambulatory outpatients than narcotic analgesics. The analgesic activity of piroxicam, a well known NSAID has been documented in many pain states. Piroxicam can be administered once daily because of its long half-life, but its absorption in the gastrointestinal tract is slow as it is its onset of action. Piroxicam-beta-cyclodextrin (PBCD) is a new formulation of piroxicam which is the product of supermolecular encapsulation of piroxicam with the cyclic oligosaccharide beta-cyclodextrin. PBCD is absorbed much faster than standard piroxicam, and its action as an analgesic is consequently more rapid. The purpose of this study was to assess the efficacy and the rapidity of action of piroxicam-beta-cyclodextrin in comparison with standard piroxicam, paracetamol and placebo following surgical extraction of impacted third molars. ⋯ One of the most commonly utilized model for the evaluation of analgesics is the third molar extraction pain. Our study clearly differentiated between active drugs and placebo. Furthermore, while PBCD and paracetamol showed a rapid effect, piroxicam was slow in inducing pain relief. The analgesic and anti-inflammatory activity of PBCD and piroxicam brought about the resolution of pain and inflammation consequent to the dental extraction. Paracetamol, a pure analgesic, was not equally active and pain persisted, even if at a low grade, throughout the observation period; probably this was due to local inflammation and edema. The results of our study appear to confirm the pharmacokinetic data on PBCD, which showed that therapeutic blood levels are reached faster with PBCD than with the standard piroxicam formulation. This results should be confirmed in studies with an adequate number of patients.