Efficacy and Tolerance of Lidocaine 5% Patches in Neuropathic Pain and Pain Related to Vaso‐occlusive Sickle Cell Crises in Children: A Prospective Multicenter Clinical Study

Background 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. Methods 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. Results 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. Conclusion 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.