Inpatient Pediatrics, Division of General Pediatrics, Case Management, Lehigh Valley Health Network, Allentown, PA, USA.
Am J Emerg Med. 2013 Jan;31(1):20-5. doi: 10.1016/j.ajem.2012.05.003. Epub 2012 Jul 16.
The aim of the study was to assess the differences in reported pain from venipuncture comparing liposomal 4% lidocaine with placebo cream in a pediatric population. Other factors assessed were patient anxiety, difficulty of venipuncture, and history of venipuncture.
A prospective, randomized, double-blind, placebo control study design was used in which subjects were assigned to receive either liposomal 4% lidocaine or placebo cream. The study population consisted of pediatric patients aged 5 to 18 years old who presented to 1 site of a multisite, academic, community emergency department. Once subjects had consented and randomized, the liposomal 4% lidocaine or placebo cream was applied for 15 minutes under occlusion. A 6-point validated FACES pain scale was used to evaluate each patient's level of pain during venipuncture. Patient anxiety was evaluated using a 100-mm visual analogue scale before, during, and after the venipuncture. Heart rate was captured as an indirect measurement of pain.
There were no significant differences between the study and placebo groups (P > .05) in mean levels of patient ratings of anxiety, patient heart rate, or the patient's mean rating of pain before, during, or after the venipuncture procedure. There was an association between increased anxiety with an increase in venipuncture pain and an inverse association between age and pain.
Topical liposomal 4% lidocaine cream in this case did not prove to be effective with a 15-minute dwell time under occlusion because there were no differences in pain between study groups.
本研究旨在评估在儿科人群中，与安慰剂乳膏相比，脂质体 4%利多卡因在静脉穿刺时报告的疼痛差异。评估的其他因素包括患者焦虑、静脉穿刺难度和静脉穿刺史。
采用前瞻性、随机、双盲、安慰剂对照的研究设计，将受试者分为接受脂质体 4%利多卡因或安慰剂乳膏的两组。研究人群包括年龄在 5 至 18 岁之间的儿科患者，他们在一个多地点学术社区急诊部就诊。一旦患者同意并随机分组，脂质体 4%利多卡因或安慰剂乳膏在封闭状态下应用 15 分钟。采用 6 分制 FACES 疼痛量表评估每位患者静脉穿刺时的疼痛程度。使用 100 毫米视觉模拟量表在静脉穿刺前、期间和之后评估患者的焦虑程度。心率作为疼痛的间接测量。
在静脉穿刺前、期间和之后，研究组和安慰剂组之间患者焦虑评分、患者心率或患者平均疼痛评分的平均水平均无显著差异（P>0.05）。静脉穿刺疼痛与焦虑增加之间存在关联，年龄与疼痛之间呈负相关。
在这种情况下，由于在封闭状态下应用 15 分钟时，局部脂质体 4%利多卡因乳膏没有显示出有效性，因此研究组之间的疼痛没有差异。
