Evaluation of piroxicam-beta-cyclodextrin, piroxicam, paracetamol and placebo in post-operative oral surgery pain.
Two hundred ninety-eight patients with post-operative pain after the surgical removal of an impacted third molar were randomly assigned, on a double-blind basis, to receive a single oral dose of piroxicam 20 mg, or piroxicam-beta-cyclodextrin equivalent to 20 mg piroxicam, or paracetamol 500 mg, or placebo. Using a semi-quantitative self-rating scale, patients rated their pain and its relief at 30-min intervals for the first 2 h, and then hourly for 4 h after treatment administration. All active medications were reported to be significantly superior to placebo. The three active drugs were comparable for the degree of analgesia up to the third hour, after which the effect of paracetamol decreased significantly as compared to piroxicam-beta-cyclodextrin and piroxicam. Piroxicam-beta-cyclodextrin and paracetamol were more rapid than piroxicam in inducing analgesia. The tolerability for the active drugs was comparable to that for placebo.
Dolci
G
G
Odontoiatric Clinic, La Sapienza University, Rome, Italy.
Ripari
M
M
Pacifici
L
L
Umile
A
A
D000082:Acetaminophen / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D003505:Cyclodextrins / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005503:Food Additives / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D008964:Molar, Third / Q000601:surgery; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology; D010894:Piroxicam / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D013515:Surgery, Oral; D011795:Surveys and Questionnaires; D014081:Tooth Extraction / Q000009:adverse effects; D047392:beta-Cyclodextrins
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003505:Cyclodextrins; D004338:Drug Combinations; D005503:Food Additives; D047392:beta-Cyclodextrins; D010894:Piroxicam; D000082:Acetaminophen; C061072:piroxicam-beta-cyclodextrin