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

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.

Trends in Adaptive Design Methods in Dialysis Clinical Trials: A Systematic Review

“…Sample-size re-estimation was the second most common type of adaptive design, used in 14 trials (24.6%); 8 (25.8%) in dialysis populations and 6 (23.1%) in dialysis outcome trials ( Table 2 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 ). Eight trials (57.1%) were affected by the use of sample-size re-estimation adaptive design including 6 trials (75%) that increased sample size.…”

Pain on arteriovenous fistula cannulation: A narrative review

“…The results are presented in Tables 1–4. We found a total of 36 studies with a variable number of patients (7–461) 9‐44 . We divided the interventions in four categories.…”

“…Local anesthetics, cryotherapy and thermotherapy, cannulation technics and AVF localization as well as other type of interventions. There were nine studies on the effects of local anesthetics’ application on the puncture sites before cannulation with 8–75 patients 10‐17,20 . The largest were the ones of Mohseni et al and Fujimoto et al with 75 and 66 patients, respectively 13,14 .…”

“…There were nine studies on the effects of local anesthetics’ application on the puncture sites before cannulation with 8–75 patients 10‐17,20 . The largest were the ones of Mohseni et al and Fujimoto et al with 75 and 66 patients, respectively 13,14 . In a randomized controlled setting they both demonstrated that Lidocaine/Prilocaine 5% application was more effective than other local interventions.…”

“…[10][11][12][13][14][15][16][17]20 The largest were the ones of Mohseni et al and Fujimoto et al with 75 and 66 patients, respectively. 13,14 In a randomized controlled setting they both demonstrated that Lidocaine/Prilocaine 5% application was more effective than other local interventions. That kind of intervention was equally more effective in other randomized controlled studies by Çelik et al (with 41 patients) and Mizraei et al (with 40 patients).…”