Journal of clinical pharmacology
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Comparative Study
A double-blind parallel comparison of ketoprofen, codeine, and placebo in patients with moderate to severe postpartum pain.
A total of 152 patients were treated at a single center in a single-dose, double-blind parallel study designed to compare the safety and efficacy of 25, 50, and 100 mg ketoprofen to 90 mg codeine and placebo in patients with moderate to severe postpartum pain (i.e., postepisiotomy, uterine cramping, or cesarean section pain). The analgesic responses to all three doses of ketoprofen and 90 mg codeine were superior to placebo and were not significantly different from each other. No dose-related response was observed with ketoprofen. The number of side effects was significantly greater (P = 0.001) among patients receiving codeine (six patients) than among those receiving ketoprofen (three patients).
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Randomized Controlled Trial Clinical Trial
The relative analgesic efficacy of propiram fumarate, codeine, aspirin, and placebo in post-impaction dental pain.
To evaluate the analgesic efficacy of orally administered 50 mg propiram fumarate, 650 mg aspirin, 60 mg codeine phosphate, and placebo in acute post-impaction dental pain, 159 patients with moderate or severe pain were randomly allocated to the four treatments in this single-dose double-blind, stratified, parallel-group study. A research nurse questioned the patients at 1/2 hour and hourly for 6 hours after medicating. ⋯ Propiram, 50 mg, produced a level of analgesia approaching that of 650 mg aspirin in peak effect, total effect, and duration of action and was statistically superior to 60 mg codeine and placebo for every measure of analgesic efficacy. Several mild adverse effects were observed; however, they appeared to be evenly distributed among the active treatments.
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Comparative Study Clinical Trial
Long-term therapy for the pain of osteoarthritis: a comparison of zomepirac sodium and aspirin.
In this long-term, double-blind, multicenter study, efficacy and safety of zomepirac sodium were compared with those of aspirin for treatment of the chronic pain associated with osteoarthritis in 607 patients, 405 of whom received zomepirac and 202 of whom received aspirin. Final evaluations during one year of treatment showed zomepirac significantly more effective than aspirin for reducing pain at rest (P = 0.02) and average pain (P = 0.04). Moreover, zomepirac was rated better than aspirin in physician global evaluations of overall response to therapy (P = 0.02) and patient evaluations of pain relief (P = 0.03). ⋯ However, complaints related to the special senses, especially tinnitus and hearing disturbances, were reported more frequently during aspirin therapy, and urogenital side effects were more common during zomepirac therapy. For both drug groups, the overall incidence of side effects was lower in the second year than in the first. This is the first published study to show a nonsteroidal antiinflammatory agent to be more effective than aspirin for the long-term treatment of pain associated with osteoarthritis.
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Comparative Study Clinical Trial
Suppression of postoperative pain by preoperative administration of ibuprofen in comparison to placebo, acetaminophen, and acetaminophen plus codeine.
The analgesic effect of preoperatively administered ibuprofen was evaluated in 107 dental outpatients undergoing the removal of impacted third molars. Subjects were given 800 mg ibuprofen prior to the procedure and 400 mg ibuprofen 4 and 8 hours later. Comparison was made to groups receiving either placebo at all three doses, 600 mg acetaminophen administered on the same schedule, or preoperatively administered placebo followed by two doses of postoperatively administered 600 mg acetaminophen plus 60 mg codeine. ⋯ Ibuprofen also resulted in less postoperative pain than acetaminophen plus codeine following the second dose. Side effects were similar across drug treatments and placebo with the exception of greater reports of drowsiness following the opiate-analgesic combination. These findings indicate that pretreatment with a nonsteroidal antiinflammatory drug, such as ibuprofen, results in a suppression of postoperative pain when compared to standard therapy without an increase in side effects.