DOSE-DEPENDENCE OF ANALGESIC ACTION OF DIPYRONE

  • 1 March 1988
    • journal article
    • research article
    • Vol. 37  (3) , 150-155
Abstract
Whereas dipyrone is used in many countries in clincial practice at doses up to 2.5 g, the dose-response relationship of the analgesic effect has not been investigated in humans. In the present study, doses of 0.5, 1.0, 1.5, 2.0, and 2.5 g dipyrone (Novalgin) were applied orally as film-coated tablets to 18 volunteers in a randomized, placebo-controlled, double-blind design. Pain attenuation was quantified following constant and painful electrical stimulation of tooth pulp at different time intervals up to 7 h after drug administration. Tooth pulp stimulation was performed by bipolar stimulation using individually formed impressions of the teeth with controlled current. Verbal pain ratings by the volunteers, measurement of the threshold of sensation on the tooth, and measurment of somatosensory evoked potential by an averaging technique were used as parameters for the quantification of the analgesic effect, intraindividually comparing the effects of the different doses. All doses of dipyrone had a significantly higher analgesic effect than placebo. Covering the dose range from 0.5-2.5 g dipyrone, the dose-response relationship was highly significant (Figs. 1-3). Maximal analgesia was observed 1 h after administration of the tablets, independent of the dose. An increase in analgesic effect related to dose was observed at this time, the increase being less pronounced with doses exceeding 1.5 g. Generally, analgesia persisted longer with increasing dose. Dipyrone 2.5 g attenuated pain after 3.5 h significantly, while after 5 h only a very slight effect was observed on the subjective pain rating. The duration of analgesia in clinical pain with comparable doses of dipyrone is similar to our results based on tooth pulp stimulation. Measurement of chemical and hemotogical parameters showed no side-effects, and the volunteers did not report and adverse reactions.

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