• Br J Clin Pharmacol · Nov 2007

    Effective dose of nefopam in 80% of patients (ED80): a study using the continual reassessment method.

    • Hélène Beloeil, Mathilde Eurin, Aude Thévenin, Dan Benhamou, and Jean-Xavier Mazoit.
    • A. P.-H. P. Hôpital Bicêtre, Département d'Anaesthésie-Réanimation, F-94275, Le Kremlin-Bicêtre, University Paris-Sud, Laboratoire d'anaesthésie, Faculté de Médecine de Bicêtre, F-94275, Le Kremlin-Bicêtre, France.
    • Br J Clin Pharmacol. 2007 Nov 1;64(5):686-93.

    AimsThe effective dose in 50% of patients (ED(50)) is far from being relevant for clinical purposes. We used the continual reassessment method (CRM) to determine the effective dose of nefopam in 80% of the patients suffering from moderate pain in the postoperative period (ED(80)).MethodsPatients with a pain intensity >3 on a 1-10 numerical pain score (NPS) received increasing or decreasing doses of nefopam (20, 30, 40, 60, 80 mg) postoperatively. The criterion of success was a NPS ResultsTwenty-four patients were enrolled. Nefopam 60 mg gave a probability of success of 0.818 (95% credibility interval 0.606-0.941). Using the maximum likelihood technique, we determined an ED(50) of 27.3 mg and a dose leading to a probability of 0.8 (ED(80)) of 74.4 mg. We did not observe a high incidence of side-effects.ConclusionsThe ED(80) of nefopam, close to 60 mg is higher than the usual dose of 20 mg. The CRM allowed us to determine the ED(80) of nefopam with reasonable accuracy in a small number of patients as compared with the classical dose-probability curve fitting. We did not observe an increased incidence of side-effects when compared with the literature or to our previous studies.

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