Open AccessComparison 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
Author(s) -
Keiji Fujimoto,
Hisashi Adachi,
Kazutoshi Yamazaki,
Kanae Nomura,
Atsushi Saito,
Yuji Matsumoto,
Kazunari Igarashi,
Hiroko Uranishi,
Suga Sakaguchi,
T Matsuura,
Junko Imura,
Kazuaki Okino,
Kiyotaka Mukai,
Yuki Okushi,
Yu Kagaya,
Yuko Tsuruyama,
Keiichiro Okada,
Nobuhiko Miyatake,
Takatoshi Haraguchi,
Yasuo Iida,
Hitoshi Yokoyama
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0230372
Subject(s) - medicine , lidocaine , anesthesia , visual analogue scale , hemodialysis , arteriovenous fistula , crossover study , surgery , randomized controlled trial , placebo , alternative medicine , pathology
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).