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Related Experiment Videos

Picenadol in a large multicenter dental pain study

D J Goldstein1, R L Brunelle, R E George

  • 1Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285.

Pharmacotherapy
|January 1, 1994
PubMed
Summary

Picenadol 22 mg was found to be as effective as codeine 60 mg for dental pain relief. Higher doses of codeine showed increased adverse events, while picenadol 30 mg was well-tolerated.

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Area of Science:

  • Pharmacology
  • Pain Management
  • Clinical Trials

Background:

  • Opioid analgesics are commonly used for moderate to severe pain.
  • Codeine is a widely used opioid analgesic, but its efficacy and side effect profile can vary.
  • Novel analgesics are needed to provide effective pain relief with improved safety profiles.

Purpose of the Study:

  • To determine the dose of picenadol hydrochloride equianalgesic to 60 mg of codeine in a dental pain model.
  • To evaluate the efficacy and safety of picenadol compared to codeine and placebo.

Main Methods:

  • A randomized, double-blind, parallel, dose-response study was conducted in four university dental clinics.
  • 408 adult patients with moderate to severe pain following third molar extraction were enrolled.

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  • Patients received single oral doses of picenadol (15 and 30 mg), codeine (30 and 90 mg), or placebo, with assessments for pain intensity, relief, and adverse events for up to 6 hours.

    • Main Results:

    • Picenadol 30 mg and codeine 90 mg demonstrated significantly greater efficacy than placebo across multiple pain assessment measures.
    • The incidence of adverse events was highest in the codeine 90 mg group compared to placebo.
    • No patients discontinued the study due to adverse events, and all reported events were transient and resolved spontaneously.

    Conclusions:

    • Picenadol 22 mg was estimated to be equianalgesic to codeine 60 mg for dental pain relief.
    • Picenadol 30 mg was found to be safe and well-tolerated in this patient population.