Tadros Andrew R, Prausnitz Mark R, Felner Eric I
Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Emory University School of Medicine, Atlanta, GA, USA.
Drug Deliv Transl Res. 2025 Jun 23. doi: 10.1007/s13346-025-01899-5.
Healthcare-related pain associated with hypodermic needles is prevalent and undertreated in pediatric patients. Currently available topical anesthetics provide insufficient pain relief due to poor drug skin permeability, especially when rapid onset is desired. Herein, our goal was to assess the speed and efficacy of local lidocaine/epinephrine/tetracaine (LET) gel enabled by STAR particles in a first-in-humans clinical trial. Twenty-two children (10 - 15 yr) were randomized in a placebo-controlled, cross-over trial to receive topical treatment of LET gel applied to the antecubital fossa for 10 or 20 min either with or without STAR particle pretreatment. STAR particle pretreatment decreased skin barrier function, demonstrated by increased trans-epidermal water loss compared to placebo (25.0 ± 8.7 g/mh vs. 14.8 ± 4.3 g/mh, P < 0.0001). STAR particle pretreatment followed by LET gel (STAR-LET group) resulted in decreased sharp sensations from needle probing after 10 min (51.6 ± 29.2% vs 82.0 ± 18.6%, P = 0.014) and 20 min (55.7 ± 21.8% vs 89.0 ± 15.6%, P = 0.006) compared to LET gel without STAR particle pretreatment (LET group). After hypodermic needle insertion, pain decreased at 10 min (3.1 ± 1.8 vs. 4.1 ± 1.9, P = 0.11) and 20 min (4.2 ± 1.0 vs. 5.3 ± 1.5, P = 0.02) in the STAR-LET group compared to the LET group. STAR particle pretreatment was described as comfortable and without pain by most participants. No adverse skin reactions were observed immediately after STAR-LET application or during the 7-day follow-up period. STAR particle skin treatment in combination with LET gel in children was safe, well-tolerated, and effective to rapidly reduce painful sensations associated with hypodermic needles. Trial Registration: Lidocaine Administration Using STAR Particles, NCT06034340, https://classic.clinicaltrials.gov/ct2/show/NCT06034340.
与皮下注射针头相关的医疗保健性疼痛在儿科患者中很普遍且治疗不足。由于药物皮肤渗透性差，目前可用的局部麻醉剂提供的疼痛缓解不足，尤其是在需要快速起效时。在此，我们的目标是在一项首次人体临床试验中评估由STAR颗粒实现的局部利多卡因/肾上腺素/丁卡因（LET）凝胶的起效速度和疗效。22名儿童（10 - 15岁）在一项安慰剂对照的交叉试验中被随机分组，接受将LET凝胶局部应用于肘前窝10或20分钟的治疗，分别有或没有STAR颗粒预处理。与安慰剂相比，STAR颗粒预处理降低了皮肤屏障功能，表现为经表皮水分流失增加（25.0±8.7g/mh对14.8±4.3g/mh，P<0.0001）。STAR颗粒预处理后再使用LET凝胶（STAR-LET组）导致在10分钟（51.6±29.2%对82.0±18.6%，P = 0.014）和20分钟（55.7±21.8%对89.0±15.6%，P = 0.006）时，与未进行STAR颗粒预处理的LET凝胶组（LET组）相比，针刺探查引起的锐痛感觉降低。皮下注射针头插入后，与LET组相比，STAR-LET组在10分钟（3.1±1.8对4.1±1.9，P = 0.11）和20分钟（4.2±1.0对5.3±1.5，P = 0.02）时疼痛减轻。大多数参与者表示STAR颗粒预处理舒适且无痛。在应用STAR-LET后或7天随访期间未观察到不良皮肤反应。在儿童中，STAR颗粒皮肤治疗与LET凝胶联合使用是安全的、耐受性良好的，并且能有效快速减轻与皮下注射针头相关的疼痛感觉。试验注册：使用STAR颗粒进行利多卡因给药，NCT06034340，https://classic.clinicaltrials.gov/ct2/show/NCT06034340 。
