Abstract
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).
Highlights
Japan is the second country with the largest number of patients receiving chronic maintenance dialysis worldwide, after the United States [1]
For patients undergoing chronic maintenance hemodialysis, the pain associated with arteriovenous fistula (AVF) punctures during each dialysis session causes a great deal of stress [3,4,5]
EMLA cream for reducing arteriovenous fistula puncture pain within 3 months prior to study drug administration, and 10) patients scheduled to move to another dialysis facility during the study period
Summary
Japan is the second country with the largest number of patients receiving chronic maintenance dialysis worldwide, after the United States [1]. For patients undergoing chronic maintenance hemodialysis, the pain associated with arteriovenous fistula (AVF) punctures during each dialysis session causes a great deal of stress [3,4,5]. In Japan, AVF accounts for a greater proportion of vascular access than in the United States (Japan, 96.8%; the United States, 55.5%) [6,7], and many patients undergo hemodialysis over a long period of time due to the small number of renal transplants; this issue represents an urgent problem. The number of patients who receive chronic maintenance hemodialysis is predicted to significantly increase worldwide [1]. AVF is predicted to become the main choice of vascular access globally, which makes AVF puncture pain an important issue for patients in Japan and worldwide
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