Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain

摘要: Objective: A randomized, crossover, double-blinded placebo-controlled and non-blinded active drug-controlled, comparative clinical trial was conducted to evaluate the efficacy safety of sublingual fentanyl tablet. Methods: Subjects were patients treated with strong opioids at fixed intervals for chronic cancer pain oral morphine as rescue medication breakthrough pain. Sublingual administered doses that 1/25th (high dose) 1/50th (low dose compared placebo morphine. The primary endpoint intensity difference 30 min after administration. (Clinical Trials Government; NCT00684632). Results: Fifty-one enrolled in investigation. Their mean visual analog scale before prior investigation 60.96 (16.44, standard deviation) mm. Compared placebo, low high showed significant analgesic effects (least squares difference, 4.54 8.49 mm; P= 0.014, P< 0.001, respectively). Adverse reactions observed 17.6%, most common being constipation, nausea somnolence. incidence adverse during high-dose administration period higher than low-dose control drug periods. Conclusions: Patients opioid analgesics up 20 mg investigated. treat determined from by use ofconversion ratios.In thesepatients,administration sublingualfentanyl atdoses determinedbya conversion ratio 1/50 effective safe. Further studies are needed validate this method.