Fenoprofen and codeine analgesia. Comparative efficacy of fenoprofen calcium and zomepirac sodium in postsurgical dental pain. A double-blind comparison of parenteral morphine, placebo, and oral fenoprofen in management of postoperative pain.
Studies were conducted on postpartum and postoperative patients to estimate the dose-response line of fenoprofen and to contrast it with codeine and placebo. The postpartum patients included women with episiotomy pain and with uterine cramping. This mix allowed contrast of ability of the various pain models to distinguish codeine from placebo. The methodology for the studies was single-dose parallel groups design with interviews conducted by trained nurse observers to obtain subjective responses. More than 850 patients participated in the trial. The results indicate that fenoprofen at doses as low as 12.5 mg has analgesic properties. In each of the five studies, the mean value of 100- and/or 200-mg doses of fenoprofen for the variable sum of the pain intensity difference (SPID) was higher than that of 65 mg codeine. The pooled relative potency calculation based on SPID suggests that 100 mg fenoprofen is approximately equivalent to 60 mg codeine. In their ability to distinguish codeine from placebo, patients with uterine cramp, episiotomy, or surgical pain did not appear to differ. The relative analgesic efficacy of zomepirac sodium 100 mg and fenoprofen calcium 200 mg was evaluated in patients with pain due to surgical removal of dental impactions. This is the first study to make a direct comparison of their effectiveness. This study is especially important since zomepirac sodium was recently removed from the market as an analgesic for acute pain. Zomepirac sodium was extremely popular among clinicians and was considered the most effective of the peripherally acting analgesics. Patients were requested to take a single dose of study medication when they had moderate to severe pain. The study medications were identical in appearance and randomly allocated under double-blind conditions. The medication was evaluated over the next 4 hours according to subjective analgesic measurement scales. The primary measures of efficacy included total pain relief ( TOTPAR ), sum pain intensity difference ( SPID ), overall evaluation, and time to remedication . Of the 136 patients entered, 117 were included in the efficacy analysis. Both active agents demonstrated marked superiority to placebo (p less than 0.001) for all efficacy measures but were inseparable from each other. The mean analgesic efficacy values for both zomepirac sodium and fenoprofen calcium were almost identical. The nineteen subjects who reported side effects were evenly distributed among the three groups. No serious side effects occurred. The results of this study indicate that fenoprofen calcium 200 mg and zomepirac sodium 100 mg are equally efficacious, with similar onset, peak, and total analgesic effects. A double-blind study comparing parenteral morphine, 8 mg, with parenteral placebo and with oral fenoprofen, 200 mg, for the relief of postoperative pain following outpatient surgery was undertaken in 90 patients. The study drugs were administered within 2 hours of the operation and the Visual Analogue Scale was used to assess pain intensity. Patients given placebos showed minimal change in mean pain intensity, whereas patients who received morphine had significantly less pain at all assessment periods. Pain relief in patients who received fenoprofen was, for the first 2 hours, better than following placebo but not as good as following morphine, but thereafter, there was no significant difference between the morphine and fenoprofen and both were significantly better than placebo. It is concluded that oral analgesics may be a useful alternative to the traditional parenteral analgesics for outpatient surgery.
Oral fenoprofen 200 mg is effective at treating moderate to severe acute postoperative pain, based on limited data for at least 50% pain relief over 4 to 6 hours. Efficacy of other doses, other efficacy outcomes, and safety and tolerability could not be assessed.