ABSTRACT
In Japan, a low-dose transdermal fentanyl (TDF; 0.5 mg) has been approved to address pain in opioid-naïve patients with cancer; however, efficacy and safety data are lacking. To determine the efficacy and safety of TDF, patients with opioid-naïve cancer pain prescribed TDF (0.5 mg/d) and oral oxycodone sustained-release formulation (OXY) 10 mg/d were extracted from electronic medical and nursing records. Overall, 40 and 101 subjects were analyzed in the TDF and OXY groups, respectively. Compared with baseline (median [minimum, maximum]) values, changes in the Numerical Rating Scale (NRS) score on days 1, 3, and 7 post-administration were as follows: TDF (0 [-5, 4]) and OXY (-1.0 [-8, 3]); TDF (-1.5 [-6, 3]) and OXY (-2.0 [-8, 4]); and TDF (-2.0[-6, 3]) and OXY (-3.0[-8, 5]), respectively. No significant difference was observed between the groups on days 1 and 3; however, the change in the NRS on day 7 was significantly higher in the OXY group than that in the TDF group. Regarding adverse events, nausea occurred in 12.5 and 13.9% of patients in the TDF and OXY groups, respectively, while 12.5% of TDF- and 10.9% of OXY-treated patients experienced somnolence, revealing similar occurrence in both groups. However, constipation was more common in the OXY group (TDF: 50.0%, OXY: 71.3%). No serious adverse events (e.g., respiratory depression) were observed in either group. Low-dose TDF (0.5 mg), available only in Japan, showed comparable efficacy and safety to OXY (10 mg/d) and can be a first choice for opioid-naïve patients with cancer pain.
Subject(s)
Cancer Pain , Neoplasms , Humans , Analgesics, Opioid/adverse effects , Fentanyl/adverse effects , Oxycodone/adverse effects , Cancer Pain/drug therapy , Analgesics , Neoplasms/complications , Neoplasms/drug therapy , Administration, CutaneousABSTRACT
AIM: To compare hemorrhoidectomy with a bipolar electrothermal device or hemorrhoidectomy using an ultrasonically activated scalpel. METHODS: Sixty patients with grade III or IV hemorrhoids were prospectively randomized to undergo closed hemorrhoidectomy assisted by bipolar diathermy (group 1) or hemorrhoidectomy with the ultrasonic scalpel (group 2). Operative data were recorded, and patients were followed at 1, 3, and 6 wk to evaluate complications. Independent assessors were assigned to obtain postoperative pain scores, oral analgesic requirement and satisfaction scores. RESULTS: Reduced intraoperative blood loss median 0.9 mL (95% CI: 0.8-3.7) vs 4.6 mL (95% CI: 3.8-7.0), P = 0.001 and a short operating time median 16 (95% CI: 14.6-18.2) min vs 31 (95% CI: 28.1-35.3) min, P < 0.0001 was observed in group 1 compared with group 2. There was a trend towards lower postoperative pain scores on day 1 group 1 median 2 (95% CI: 1.8-3.5) vs group 2 median 3 (95% CI: 2.6-4.2), P = 0.135. Reduced oral analgesic requirement during postoperative 24 h after operation median 1 (95% CI: 0.4-0.9) tablet vs 1 (95% CI: 0.9-1.3) tablet, P = 0.006 was observed in group 1 compared with group 2. There was no difference between the two groups in the degree of patient satisfaction or number of postoperative complications. CONCLUSION: Bipolar diathermy hemorrhoidectomy is quick and bloodless and, although as painful as closed hemorrhoidectomy with the ultrasonic scalpel, is associated with a reduced analgesic requirement immediately after operation.