Journal Article

Comparison of the pain-reducing effects of EMLA cream and of lidocaine tape during arteriovenous fistula puncture in patients undergoing hemodialysis: A multi-center, open-label, randomized crossover trial

Hitoshi Yokoyama, Yu Kagaya, Atsushi Saito, Keita Yamazaki, Takatoshi Haraguchi, Hiroko Uranishi, Kanae Nomura, Kazunari Igarashi, Yuko Tsuruyama, Suga Sakaguchi, Keiji Fujimoto, Toshikazu Matsuura, Keiichiro Okada, Nobuhiko Miyatake, Kiyotaka Mukai, Hiroki Adachi, Yuji Matsumoto, Yuki Okushi, Kazuaki Okino, Yasuo Iida, Junko Imura

2020

Overview

Arteriovenous fistula puncture pain is a serious problem for patients undergoing dialysis and a good indication for topical anesthetics. No previous study has compared lidocaine/prilocaine cream (EMLA) with lidocaine tape for pain relief during arteriovenous fistula puncture in patients undergoing maintenance hemodialysis. To this end, we conducted a multicenter randomized crossover study including 66 patients (mean age, 65.8 years; males, 57.6%) undergoing maintenance hemodialysis thrice/week. Subjects were assigned to Sequence EL (EMLA administration followed by lidocaine, with 1-week wash-out) or Sequence LE (reverse administration, first lidocaine then EMLA). All subjects completed the study. At each puncture site, 1 g EMLA (25 mg lidocaine + 25 mg prilocaine) or one sheet of lidocaine tape (18 mg lidocaine) was applied 1 h or 30 min prior to arteriovenous fistula puncture, respectively. The primary endpoint was puncture pain relief, which was measured using a 100-mm visual analog scale. The secondary endpoints included quality of life, which was measured by SF-36, and safety. EMLA produced a 10.1-mm greater visual analog scale improvement than lidocaine tape (P = 0.00001). However, there was no statistically significant difference in the quality of life between the two groups, and no significant carryover/period effect was observed in any analysis. Further, no drug-related adverse events were observed. Taken together, these results suggest that EMLA cream is superior to lidocaine tape for the relief of arteriovenous fistula puncture pain in patients undergoing maintenance hemodialysis. Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000027885).

• Publisher: Public Library of Science (PLoS),Public Library of Science
• Subject: Aged / Analgesia / Anesthesia / Anesthetics / Anesthetics, Local / Arteriovenous fistula / Arteriovenous Shunt, Surgical / Biology and Life Sciences / Central nervous system agents / Clinical trials / Comparative analysis / Cross-Over Studies / Dialysis / Dose-Response Relationship, Drug / Drug Administration Schedule / Female / Fistula / Fistulae / Fistulas / Food safety / Hemodialysis / Hospitals / Humans / Japan / Kidney Failure, Chronic / Lidocaine / Lidocaine, Prilocaine Drug Combination / Maintenance / Male / Medical research / Medicine / Medicine and Health Sciences / Methods / Middle Aged / Nephrology / Pain / Pain management / Pain Measurement / Pain, Procedural / Patients / People and Places / Permeability / Prilocaine / Punctures / Q / Quality of life / R / Randomization / Registration / Renal Dialysis / Research Article / Researchers / Respiratory system agents / Science / Skin Cream / Social Sciences / Statistical analysis / Studies / Topical analgesics