Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, EA3878 (GETBO) CIC INSERM 1412, European University of Occidental Brittany, Morlaix, France.
Department of Internal Medicine and Chest Diseases, EA3878 (GETBO) CIC INSERM 1412, University Hospital of Brest, European University of Occidental Brittany, Brest, France.
Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.
Arterial puncture is often painful for patients. The aim of this study was to compare use of local anesthesia as a eutectic mixture of 2 local anesthetics, lidocaine and prilocaine, versus placebo.
We conducted a double-blind, randomized controlled trial. Subjects were eligible if arterial puncture was indicated. The primary outcome was an experienced pain > 2 on a numerical pain rating scale. As having had a previous experience of arterial puncture was expected to be predictive of the current response, we planned 3 comparisons between use of local anesthesia and placebo: in the whole sample, among subjects with a painful previous experience, and among subjects with a painless previous experience. Multiple testing was analyzed using the Bonferroni correction for the primary outcome. The secondary outcome was the numerical pain rating scale score itself. All analyses were performed on an intention-to-treat basis.
A total of 136 subjects were included in this study. The primary outcome occurred in 20.9% in the active arm versus 37.7% in the placebo arm in the whole sample (relative risk 0.55; 95% CI when adjusting for multiple testing ranged was 0.28-1.09, = .10; 95% CI without adjustment was 0.32-0.97, = .038). No significant heterogeneity in the study treatment effect was found when considering previous painful or painless arterial puncture ( = .70). The numerical pain rating scale score was 1.55 ± 2.03 in active group versus 2.09 ± 2.15 in the placebo group ( = .13).
We found that application of a eutectic mixture reduced the number of painful arterial punctures by 50% compared with placebo. However, this result was not statistically significant. (ClinicalTrials.gov registration NCT01964248.).
动脉穿刺常常给患者带来疼痛。本研究旨在比较使用局部麻醉剂(利多卡因和丙胺卡因的混合制剂)与安慰剂。
我们进行了一项双盲、随机对照试验。如果需要进行动脉穿刺,则符合入选标准。主要结局为数字疼痛评分量表上的疼痛评分>2。由于先前有动脉穿刺史可能会预测当前的反应,因此我们计划在以下 3 种情况下比较局部麻醉与安慰剂的效果:在整个样本中、在有疼痛史的患者中、在无疼痛史的患者中。采用 Bonferroni 校正对主要结局进行多重检验分析。次要结局为数字疼痛评分量表评分本身。所有分析均基于意向治疗原则进行。
共有 136 名患者纳入本研究。在整个样本中,实验组的主要结局发生率为 20.9%,安慰剂组为 37.7%(相对风险 0.55;调整多重检验后,95%CI 范围为 0.28-1.09,P=.10;未调整的 95%CI 为 0.32-0.97,P=.038)。当考虑先前有疼痛或无疼痛的动脉穿刺史时,研究治疗效果无显著异质性(P=.70)。实验组的数字疼痛评分量表评分为 1.55±2.03,安慰剂组为 2.09±2.15(P=.13)。
与安慰剂相比,应用局部麻醉剂可使疼痛性动脉穿刺的发生率降低 50%,但无统计学意义。(临床试验注册号:NCT01964248。)