Clinic of Anesthesiology and Intensive Care Medicine, Philipps-University Marburg; UKGM Giessen and Marburg.
Dtsch Arztebl Int. 2017 Sep 15;114(37):605-611. doi: 10.3238/arztebl.2017.0605.
The pain of venous puncture for the cannulation of peripheral veins is disturbing to many patients. This is the first clinical trial of the efficacy of local anesthesia in comparison to placebo (no pretreatment) in a control group, as a function of the size of the cannula.
A randomized, controlled trial of fully factorial design was performed to study pain during venipuncture after local anesthesia either with intra - dermally injected lidocaine or with a vapocoolant spray, in comparison to placebo. A standardized protocol was used for structured communication with the patient to provide the greatest feasible degree of patient blinding (trial registration number DRKS00010155). The primary endpoints were the subjective discomfort of the patient during preparation and puncture of a vein of the dorsum of the hand, assessed on a numerical rating scale (NRS) from 0 (no discomfort) to 10 (unbearable discomfort), and the rate of unsuccessful puncture.
The intention-to-treat analysis of all 450 patients revealed that the reported degree of pain during venipuncture depended to a large extent on the caliber of the chosen venous cannula. For a 17-gauge (17G) cannula, both the vapocoolant spray (NRS = 2.6 ± 1.3) and lidocaine (NRS = 3.5 ± 2.2) lessened the discomfort due to venipuncture compared to control treatment (5.0 ± 1.5). The effect of vapocoolant spray compared to the control was both clinically relevant and statistically significant (p < 0.0001). When a smaller 20G cannula was used, however, vapocoolant spray improved discomfort by only 0.8 NRS points, which, though still statistically significant (p = 0.0056), was no longer clinically relevant. The rate of unsuccessful puncture was higher after lidocaine pretreatment (12.7%) than after either vapocoolant spray (4.7%; p = 0.0066) or no pretreatment (4.0%; p = 0.0014).
Local anesthesia can be recommended before venipuncture only if a large cannula is used (e.g., ≥ 17G). Vapocoolant spray may be at least as useful as lidocaine injection; it prevents pain to a similar extent and is associated with a lower rate of unsuccessful puncture.
外周静脉置管时的静脉穿刺疼痛令许多患者感到不适。这是首次比较局部麻醉与安慰剂(无预处理)在对照组中的疗效的临床试验,且以导管的大小为研究因素。
本完全析因设计的随机对照试验旨在研究利多卡因皮内注射或 vapocoolant 喷雾局部麻醉后行手背静脉穿刺时的疼痛,与安慰剂进行比较。采用标准化方案与患者进行结构化沟通,以提供最大程度的患者盲法(DRKS00010155 号试验注册)。主要终点为患者在准备和穿刺手背静脉时的主观不适程度,使用数字评分量表(NRS)从 0(无不适)到 10(无法忍受的不适)进行评估,以及穿刺失败率。
对所有 450 例患者的意向治疗分析显示,静脉穿刺过程中的疼痛报告程度在很大程度上取决于所选静脉导管的口径。对于 17 号(17G)导管,与对照组(NRS = 5.0 ± 1.5)相比, vapocoolant 喷雾(NRS = 2.6 ± 1.3)和利多卡因(NRS = 3.5 ± 2.2)均减轻了静脉穿刺引起的不适。与对照组相比, vapocoolant 喷雾的效果具有临床意义且统计学显著(p < 0.0001)。然而,当使用较小的 20G 导管时, vapocoolant 喷雾仅将不适程度改善了 0.8 NRS 点,虽然仍具有统计学意义(p = 0.0056),但不再具有临床意义。利多卡因预处理后穿刺失败率较高(12.7%),而 vapocoolant 喷雾(4.7%;p = 0.0066)或无预处理(4.0%;p = 0.0014)后则较低。
仅在使用大口径导管(如≥17G)时,静脉穿刺前才推荐使用局部麻醉。 vapocoolant 喷雾可能与利多卡因注射同样有用;它可防止疼痛,且穿刺失败率较低。