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

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

Transparent hood attached to the colonoscope: does it really work for all types of colonoscopes?

BACKGROUND: Recently the use of a transparent hood attached to the tip of the colonoscope has been reported to be useful in cecal intubation, especially in difficult colonoscopy cases. However, patient comfort with or without the use of a transparent hood, the type of colonoscope most suitable for this device have not been fully evaluated. METHODS: A total of 372 patients undergoing routine colonoscopy were evaluated. No sedatives were used as a principle, and patients with prior abdominal surgery were excluded. A single endoscopist performed all the examinations. Four types of colonoscopes were used: CF-230I and CF-Q240AI as a standard colonoscope, PCF-240I and PCF-P240AI as a small-caliber colonoscope (Olympus, Tokyo, Japan). A disposable transparent hood was used (Olympus, Tokyo, Japan). Patients were randomly divided into four groups; standard colonoscope without transparent hood (96 patients), standard colonoscope with transparent hood (82 patients), small-caliber colonoscope without transparent hood (102 patients), and small-caliber colonoscope with transparent hood (92 patients). Cecal intubation time, rate, modified visual analogue scale (VAS) of patient's pain, and technical difficulty were evaluated among the four groups. RESULTS: Standard colonoscope with the transparent hood showed the shortest cecal intubation time, and lowest modified VAS scale of pain and technical difficulty among the four groups. However there was no significant difference with regard to small-caliber colonoscopes with or without the transparent hood. CONCLUSIONS: Transparent hood may be a handy and a cost-effective device for reducing pain and simplifying cecal intubation, especially when using a standard adult colonoscope in routine colonoscopy.