Traitement de la douleur après avulsion dentaire : essai clinique randomisé en double aveugle comparant deux formulations de paracétamol, caféine et poudre d’opium versus tramadol et placebo

• Published in: La Presse médicale (1983) 2010-05, Vol.39 (5), p.e103-e111
• Main Authors: Borel, Jean-François, Deschaumes, Christophe, Devoize, Laurent, Huard, Cédric, Orliaguet, Thierry, Dubray, Claude, Baudet-Pommel, Martine, Dallel, Radhouane
• Format: Article
• Language: fre
• Subjects: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Caffeine; Central Nervous System Stimulants; Chemistry, Pharmaceutical; Double-Blind Method; Drug Combinations; Female; Follow-Up Studies; Human health and pathology; Humans; Life Sciences; Male; Molar, Third; Opium; Pain Measurement; Pain, Postoperative; Placebos; Safety; Surgery; Tooth Extraction; Tooth, Impacted; Tramadol; Treatment Outcome; Young Adult
• ISSN: 0755-4982; 2213-0276
• DOI: 10.1016/j.lpm.2009.09.025

The aim of this study was to evaluate the analgesic efficacy and the safety of the association, paracetamol, opium prepared and caffeine, in two different dosages as compared to the conventional analgesic tramadol hydrochloride, on acute postoperative dental pain. We conducted a randomised, double-blind, multicentre, parallel-group clinical trial to test the efficacy and safety of single doses of two associations; paracetamol 500 mg, caffeine 50 mg, opium prepared 25, and paracetamol 500 mg, caffeine 50 mg, opium prepared 50 mg, as compared to tramadol hydrochloride 100 mg (called hereafter tramadol 100), and placebo, in the control of postoperative pain following the removal of 2 ipsilateral impacted third molars. The primary efficacy criterion was the sum of pain intensity differences as assessed every 30 minutes within 3 hours after the baseline assessment and administration of study treatment (SPID 0–3 h ). Of the 232 randomised patients, 228 (98%) completed the study. Analysis of the primary efficacy criterion (SPID 0–3 h ) established: (i) the superiority of the 3 active study treatments vs. placebo ( p < 0.005); (ii) non-inferiority of paracetamol, caffeine, and opium 25 mg, and paracetamol, caffeine, and opium 50 mg vs. tramadol. Besides, both formulations of paracetamol, caffeine, and opium showed: (i) a faster onset of analgesic effect as compared to tramadol 100; (ii) a significantly stronger analgesic efficacy than tramadol 100, as measured 1 hour after the treatment intake; this superiority lasted all over the study duration for paracetamol, cafeine, and opium 50 mg but not for paracetamol, caffeine, and opium 25 mg. No unexpected safety concerns occurred, the two formulations of paracetamol, caffeine, and opium showed a good safety profile especially with paracetamol, caffeine, and opium 25 mg as compared to tramadol. This study evidenced the non-inferiority of the paracetamol, caffeine, and opium 25 mg or 50 mg vs. tramadol 100, and even though the strengths of the tested formulations were higher than that of the 2009, commercialised formulation of paracetamol, caffeine, and opium, efficacy was not offset by an alteration of the well recognised safety profile of the less strengthened formulation of the product being in use for decades. L’objectif de cette étude était d’évaluer l’efficacité antalgique et la tolérance de deux nouvelles formulations, associant dans de nouveaux rapports de doses paracétamol, caféine et poudre d’opium dans le tra