Analgesic efficacy of piroxicam in the treatment of postoperative pain. Piroxicam, acetylsalicylic acid and placebo for postoperative pain. Evaluation of piroxicam-beta-cyclodextrin, piroxicam, paracetamol and placebo in post-operative oral surgery pain. Multimodal analgesia before thoracic surgery does not reduce postoperative pain. A double-blind, placebo-controlled study comparing three single-dose regimens of piroxicam with ibuprofen in patients with primary dysmenorrhea. Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis. Comparative efficacy of oral flurbiprofen, intramuscular morphine sulfate, and placebo in the treatment of gynecologic postoperative pain. Piroxicam 0.5% topical gel compared to placebo in the treatment of acute soft tissue injuries: a double-blind study comparing efficacy and safety. A double blind, placebo controlled study of piroxicam in the management of acute musculoskeletal disorders.
Two randomized, double-blind, single-dose studies were conducted to assess the analgesic efficacy and safety of piroxicam for the treatment of moderate or severe postoperative pain. Study 1 evaluated the analgesic efficacy of piroxicam 20 mg compared with that of codeine sulfate 60 mg and placebo. A final patient population of 149 subjects rated pain intensity and pain relief at one half hour and one hour following treatment and then hourly for six hours, with a global assessment made at the completion of 24 hours. Piroxicam 20 mg was significantly more efficacious than placebo for all analgesic variables, including the sum of the pain intensity differences (SPID), total pain relief (TOTAL), percent SPID, duration of effect, and time to remedication. Codeine 60 mg was significantly superior to placebo for percent SPID and some hourly measures. Piroxicam 20 mg was significantly more effective than codeine 60 mg for percent SPID and a few hourly measures including time to remedication. Study 2 assessed the efficacy of piroxicam 20 mg or 40 mg compared with aspirin 648 mg and placebo. Sixty patients rated their pain intensity and relief hourly for 12 hours and at 24 hours after administration of study medication. Both doses of piroxicam were significantly more effective than placebo from Hours 2 to 12 for pain intensity difference (PID) and relief scores, as well as for SPID and TOTAL. Aspirin was significantly more effective than placebo from Hours 2 to 8 for relief and Hours 2 to 10 for PID as well as SPID and TOTAL. Piroxicam 40 mg was significantly more effective than aspirin 648 mg for SPID, TOTAL, and hourly measures beginning with Hour 6 through Hour 12. Piroxicam 20 mg was significantly better than aspirin for a few hourly measures: Hours 7 to 9 for relief and Hour 7 for PID. In addition, effects of piroxicam 20 mg had a significantly longer duration than aspirin. Similarly, piroxicam 20 mg had a significantly longer time to remedication compared with aspirin and placebo. The results of these studies provide evidence in support of the longer duration of analgesic efficacy of piroxicam compared with codeine or aspirin in patients with postoperative pain. A double-blind comparison of the pain-relieving effect of piroxicam 5 and 10 mg, acetylsalicylic acid 648 mg and placebo was performed in 120 patients with moderate to severe pain on the morning after orthopedic surgery. The changes in pain intensity and pain relief during the 8 h following medication were recorded by a trained nurse observer. 67% of the placebo-treated patients needed rescue drugs compared to 41% of the acetylsalicylic acid, 43% of the piroxicam 5 mg, and 45% of the piroxicam 10 mg treated patients. One to three hours after ingestion of the test drug, the piroxicam and the acetylsalicylic acid groups had significantly improved verbal rating pain intensity scores compared to placebo. In the overall assessment of pain relief at the end of the observation period, the patients' own assessment was significantly superior for acetylsalicylic acid and piroxicam 10 mg compared with placebo. In the observer's assessment of overall pain relief, placebo was significantly inferior to the three other groups. Thus piroxicam 5 mg and 10 mg give relief of pain after orthopedic surgery similar to that given by acetylsalicylic acid 648 mg. The pain-relieving effect of these drugs can be distinguished from placebo, but not from each other. They are not potent enough when pain is moderate to severe after orthopedic surgery. 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. Several reports have suggested that preoperative nociceptive block may reduce postoperative pain, analgesic requirements, or both, beyond the anticipated duration of action of the analgesic agents. We have investigated, in a double-blind, placebo-controlled study, pre-emptive analgesia and the respiratory effects of preoperative administration of a multimodal antinociceptive regimen. Thirty patients undergoing thoracotomy were allocated randomly to two groups. Before surgery, the treatment group (n = 15) received morphine 0.15 mg kg-1 i.m. with perphenazine 0.03 mg kg-1 i.m. and a rectal suppository of indomethacin 100 mg, while the placebo group (n = 15) received midazolam 0.05 mg kg-1 i.m. and a placebo rectal suppository. After induction of anaesthesia, the treatment group received intercostal nerve block with 0.5% bupivacaine and adrenaline 1:200,000 (3 ml) in the interspace of the incision and in the two spaces above and two spaces below. The placebo group received identical injections but with normal saline only. The treatment group consumed significantly less morphine by patient-controlled analgesia in the first 6 h after operation, but the total dose of morphine consumed on days 2 and 3 after surgery was significantly greater in the treatment group. There were no differences between the groups in postoperative VAS scores (at rest or after movement), PaCO2 values or postoperative spirometry. However, pain thresholds to pressure applied at the side of the chest contralateral to the site of incision decreased significantly from preoperative values on days 1 and 2 after surgery in both groups. The results of this study do not support the preoperative use of this combined regimen for post-thoracotomy pain. Sixty-eight women with primary dysmenorrhea were randomly assigned to one of five four-times-daily treatment groups for a minimum of three days and a maximum of five days. Three of the groups received different initial single-daily doses of piroxicam, which were followed on each treatment day with placebo for the second through fourth doses, namely, piroxicam 20 mg daily for five days (piroxicam 20 mg for five days); piroxicam 40 mg on Day 1, followed by piroxicam 20 mg on Days 2 through 5 (piroxicam 40 mg for one day); and piroxicam 40 mg on Days 1 and 2, followed by piroxicam 20 mg on Days 3 through 5 (piroxicam 40 mg for two days). The fourth group received ibuprofen 400 mg four times per day, and the fifth group received placebo four times per day. Patients determined the severity of overall discomfort and pelvic-abdominal pain at baseline and prior to each dose using a four-point numerical scale. Supplemental ibuprofen, 400 mg four times per day, was provided for those patients requiring additional pain relief. Patients also made a global determination of overall relief at the end of the study. At 24 hours, the results revealed that piroxicam 40 mg for two days, piroxicam 20 mg for five days, and ibuprofen provided significantly more relief of overall discomfort compared with placebo (p = 0.003, p = 0.018, and p = 0.026, respectively). All four active treatment groups also experienced significantly more relief of pelvic-abdominal pain compared with placebo: piroxicam 40 mg for two days followed by three days of 20 mg (p = 0.002), piroxicam 40 mg for one day followed by four days of 20 mg (p = 0.023), piroxicam 20 mg for five days (p = 0.012), and ibuprofen (p = 0.011). A significantly smaller percentage of patients treated with piroxicam 40 mg for two days required supplemental medication as compared with those treated with piroxicam 20 mg for five days (p = 0.035) and patients treated with placebo (p = 0.010). A greater amount of overall relief was obtained by patients treated with piroxicam 40 mg for two days compared with patients treated with piroxicam 40 mg for one day (p = 0.041) and placebo-treated patients (p = 0.001). It was concluded that single daily doses of piroxicam 20 mg and 40 mg were as effective as ibuprofen, 400 mg four times per day, for the relief of primary dysmenorrhea. To compare the efficacy and gastroduodenal safety of a fixed-dose combination of diclofenac sodium 50 mg and misoprostol 200 micrograms twice daily with those of piroxicam 10 mg twice daily and naproxen 375 mg twice daily in patients with osteoarthritis.
                A 4 week, randomised, double-blind, parallel-group, multicentre study was conducted in 643 patients with symptomatic osteoarthritis of the hip and/or knee, who required continuous non-steroidal anti-inflammatory drug therapy for 4 weeks and who were without significant upper gastrointestinal damage as confirmed by endoscopy.
                For patients who had pre- and post-treatment endoscopic examinations, gastroduodenal ulcers developed in 3 (1.5%) of 200 patients treated with diclofenac/misoprostol, 21 (10.3%) of 204 piroxicam-treated patients, and 17 (8.6%) of 198 patients receiving naproxen (Chi square = 13.771, p = 0.001). The improvement in the osteoarthritis severity index was greater in the diclofenac/misoprostol group than in the piroxicam group (p = 0.004). Changes in physician and patient global assessments showed no significant differences between treatment groups. The incidences of diarrhoea and abdominal pain were higher in the diclofenac/misoprostol group than in the piroxicam and naproxen groups.
                Diclofenac/misoprostol at twice daily dosing is associated with significantly fewer gastroduodenal ulcers than either piroxicam or naproxen. The efficacy of diclofenac/misoprostol in treating the signs and symptoms of osteoarthritis is at least comparable to that of piroxicam and naproxen. This single-dose, double-blind, randomized, placebo-controlled study compared the efficacy of 50 mg of oral flurbiprofen (Ansaid, Upjohn), 10 mg of intramuscular morphine sulfate, and placebo in 92 patients with moderate to severe postoperative gynecologic pain. According to pain intensity, pain relief, and pain intensity difference scores, the morphine-treated patients experienced significantly more pain reduction than the other patients by the first hour after treatment. The flurbiprofen group obtained the same level of significant pain relief as the morphine group by two hours after dosing, but relief persisted longer than in the morphine-treated patients. Evaluation of other efficacy variables revealed similar levels of significant pain reduction in both the flurbiprofen and morphine groups compared with the placebo group. Flurbiprofen was well tolerated and led to fewer side effects than either morphine or placebo. Piroxicam 0.5% gel, administered as 5 mg q.i.d. was compared to placebo gel in a double-blind study of the treatment of selected acute soft tissue injuries (ankle or acromioclavicular sprains, supraspinatus, or achilles tendinitis). A total of 200 patients (100 per treatment) were evaluated. Six patients (6%) in the piroxicam group discontinued treatment due to inefficacy, compared to 42/100 in the placebo group (p less than 0.001). Significantly greater reduction in pain (spontaneous and on movement), degree of joint restriction, pressure threshold and tenderness of the affected site were observed with piroxicam gel compared to placebo gel. The time to improvement was significantly less with the piroxicam gel. The overall evaluation of efficacy and of benefit to injury favoured piroxicam over placebo (p less than 0.0001). Both piroxicam and placebo gels were well tolerated, with 7 piroxicam and 15 placebo patients reporting primarily skin-related adverse effects. This study indicates that piroxicam 0.5% gel, administered as 5 mg q.i.d. is an effective treatment of musculoskeletal injuries (sprains and tendinitis), is significantly more effective than placebo, and is well tolerated. General Practitioners from the United Kingdom produced data on 1,282 patients with acute soft tissue injury treated with either piroxicam (Feldene) or matching placebo for a period of up to two weeks. The dosage of piroxicam was 40 mg for the first 2 days and 20 mg daily thereafter. Clinical assessment included pain, swelling, limitation of active and passive movement and overall assessment of efficacy and toleration. Piroxicam was significantly better than placebo in improving patient signs and symptoms, and in its overall efficacy (P less than 0.001); 87% of piroxicam treated patients had excellent or good responses, compared to 53% of placebo treated patients. On analysis of four of the most commonly occurring diagnoses (injuries of ankle, knee, shoulder, back) patients with moderate or severe pain showed a significant improvement on treatment with piroxicam. Physicians' overall assessment of toleration showed no evidence of differences between treatments. Over 90% of patients in both treatment groups had good or excellent toleration. Withdrawals due to side effects were 3% and 2.5% respectively for piroxicam and placebo treated patients.
Piroxicam appears to be of similar efficacy to other NSAIDs and intramuscular morphine 10 mg when used as a single oral dose in the treatment of moderate to severe postoperative pain.