Desai Chiragkumar, Wood Fiona M, Schug Stephan A, Parsons Richard W, Fridlender Charles, Sunderland Vivian Bruce
School of Pharmacy, Curtin Health Innovation Research Institute, Curtin University of Technology, Perth, Western Australia, Australia; N S Technologies Pty Ltd., Perth, WA 6050, Australia.
Burn Injury Research Unit, School of Surgery, University of Western Australia, Burn Service of Western Australia, Royal Perth Hospital, Perth, WA, Australia.
Burns. 2014 Feb;40(1):106-12. doi: 10.1016/j.burns.2013.05.013. Epub 2013 Jun 27.
Partial thickness skin graft wounds are painful. Topically applied lidocaine has been used for analgesia in several clinical trials. This study compared the effectiveness of two different formulations of topical local anaesthetic for dressing changes of partial thickness skin graft donor sites.
A double-blind randomised controlled, pilot trial was conducted in 29 patients undergoing split thickness skin graft surgery. Subjects were randomised to either a 3% lidocaine emulsion formulation "Treatment E" (NOPAYNE™) or a 4% aqueous solution "Treatment A" (Xylocaine™). Subjects received one spray per 3 cm(2) of donor site area followed by up to two further spays as required. Endpoints included pain intensity measured by the numerical rating scale (NRS) up to 1h after dressing change commencement, sting sensation, overall satisfaction and lidocaine plasma concentration.
The 60 min pain scores for E and A were 1.3 ± 0.3 (mean ± SEM) and 1.8 ± 0.4 (p=0.98) respectively. Nearly 90% of patients were very satisfied with their treatment. The mean plasma concentrations of lidocaine for A and E were 0.132 mg/l and 0.040 mg/l respectively (p=0.069).
The topical local anaesthetic formulations achieved low pain scores during dressing changes. The safety profile was potentially improved with the emulsion formulation of lidocaine.
部分厚度皮肤移植伤口会产生疼痛。在多项临床试验中，局部应用利多卡因已被用于镇痛。本研究比较了两种不同剂型的局部麻醉剂用于部分厚度皮肤移植供区换药时的有效性。
对29例行中厚皮片移植手术的患者进行了一项双盲随机对照试验。受试者被随机分为3%利多卡因乳剂配方“治疗E”（NOPAYNE™）或4%水溶液“治疗A”（赛罗卡因™）。受试者每3平方厘米供区面积接受一次喷雾，必要时可再进行两次喷雾。观察指标包括换药开始后1小时内用数字评分量表（NRS）测量的疼痛强度、刺痛感、总体满意度和利多卡因血浆浓度。
E组和A组60分钟时的疼痛评分分别为1.3±0.3（平均值±标准误）和1.8±0.4（p=0.98）。近90%的患者对其治疗非常满意。A组和E组利多卡因的平均血浆浓度分别为0.132mg/L和0.040mg/L（p=0.069）。
局部麻醉剂剂型在换药期间疼痛评分较低。利多卡因乳剂配方可能改善了安全性。
