Rousseau Vanessa, Morelle Magali, Arriuberge Céline, Darnis Sophie, Chabaud Sylvie, Launay Valérie, Thouvenin Sandrine, Roumenoff-Turcant Fabienne, Metzger Séverine, Tourniaire Barbara, Marec-Berard Perrine
Emergency Department and Pediatric Resuscitation, Civil Hospitals of Lyon, Mother-Child Hospital, Bron, France.
Léon Bérard Center, Institute of Hematology and Pediatric Oncology, Lyon, France.
Pain Pract. 2018 Jul;18(6):788-797. doi: 10.1111/papr.12674. Epub 2018 Feb 28.
The management of neuropathic pain and pain related to bone vaso-occlusive crises in sickle cell disease remains challenging in children. Lidocaine 5% patches are recommended in adults for neuropathic pain treatment, but they are not recommended in children. The purpose of this study was to assess the efficacy and tolerance of lidocaine 5% patches in pediatric inpatients.
This prospective, multicenter, single-arm, phase II study aimed to assess the use of lidocaine 5% patches in 6- to 21-year-old pediatric patients suffering from neuropathic pain or superficial bone vaso-occlusive crises. Patches were applied on the painful area for 12 hours a day. The primary endpoint was the proportion of inpatients with significant pain relief defined as a decrease of at least 2 points on the visual analog pain scale (VAS) measured at 12 hours after patch placement over at least 2 consecutive days.
The 12-hour VAS score decreased by at least 2 points over 2 consecutive days in 48.6% of patients 95% unilateral confidence interval (33.8%). Only 7.7% of patients experienced grade 1 or grade 2 toxicities.
Although lidocaine 5% patches decreased the pain's intensity in nearly half of the enrolled patients with an excellent tolerance, the efficacy endpoint was not reached. Further studies should consider a more refined selection of the experimental population to assess the efficacy of lidocaine 5% patches in the pediatric population.
镰状细胞病患儿的神经性疼痛以及与骨血管闭塞性危象相关的疼痛管理仍然具有挑战性。5%利多卡因贴剂在成人神经性疼痛治疗中被推荐使用，但不推荐用于儿童。本研究的目的是评估5%利多卡因贴剂在儿科住院患者中的疗效和耐受性。
这项前瞻性、多中心、单臂、II期研究旨在评估5%利多卡因贴剂在6至21岁患有神经性疼痛或浅表骨血管闭塞性危象的儿科患者中的使用情况。贴剂每天在疼痛部位贴敷12小时。主要终点是在贴剂放置后12小时测量的视觉模拟疼痛量表（VAS）上疼痛显著缓解（定义为至少降低2分）的住院患者比例，且至少连续2天如此。
48.6%的患者在连续2天内12小时VAS评分至少降低2分（95%单侧置信区间为33.8%）。只有7.7%的患者出现1级或2级毒性反应。
尽管5%利多卡因贴剂使近一半入组患者的疼痛强度降低，且耐受性良好，但未达到疗效终点。进一步的研究应考虑更精细地选择实验人群，以评估5%利多卡因贴剂在儿科人群中的疗效。
