Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Apr 1994
Randomized Controlled Trial Comparative Study Clinical TrialA placebo-controlled model to assay the onset of action of nonprescription-strength analgesic drugs.
The definition and detection of the onset of analgesic drug activity represent two of the more complicated methodologic challenges in clinical pharmacology. We addressed these issues by designing an analgesic assay with frequent posttreatment assessments to identify the first time when a subject experienced relief and when a nonprescription-strength analgesic could be distinguished from placebo. To test the feasibility of conducting this assay, 29 subjects with acute sore throat were randomized to receive 200 mg ibuprofen, 400 mg ibuprofen, or placebo under double-blind conditions. ⋯ Subjects completed each series of assessments efficiently, most within 5 seconds. Each active agent was differentiated from placebo early after treatment (p < or = 0.05), and there was dose-separation. We conclude that the sore throat pain model can be used to evaluate the onset of action of nonprescription-strength analgesic agents.
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Clin. Pharmacol. Ther. · Nov 1993
Randomized Controlled Trial Clinical TrialKetoprofen, acetaminophen plus oxycodone, and acetaminophen in the relief of postoperative pain.
Ketoprofen (Orudis) is a nonsteroidal anti-inflammatory drug that is currently approved in the United States for the management of mild to moderate pain. The objective of this trial was to determine the effectiveness of orally administered ketoprofen in the management of severe postoperative pain. This randomized, double-blind parallel study compared the efficacy and safety of single doses of 100 mg or 50 mg ketoprofen, the combination of 650 mg acetaminophen plus 10 mg oxycodone hydrochloride, 650 mg acetaminophen, or placebo in 240 patients with severe postoperative pain after cesarean section. ⋯ Remedication time for the group receiving 100 mg ketoprofen was significantly longer than for the other treatment groups. Significantly more patients who took repeated doses of the combination (84%) than those who took either dose of ketoprofen (70%) had adverse effects. Ketoprofen at both dose levels was shown to be effective, long-lasting, and well tolerated, and it should be considered as a viable option for the management of moderate to severe postoperative pain.