Smith G A, Strausbaugh S D, Harbeck-Weber C, Cohen D M, Shields B J, Powers J D
Division of Emergency Medicine, Children's Hospital, Columbus, Ohio 43205, USA.
Pediatrics. 1997 Nov;100(5):825-30. doi: 10.1542/peds.100.5.825.
To compare the effectiveness of three new topical anesthetics that do not contain cocaine (prilocaine-phenylephrine, tetracaine-phenylephrine [tetraphen], and tetracaine-lidocaine-phenylephrine) to that of tetracaine-adrenaline-cocaine (TAC) during laceration repair in children.
Prospective, randomized, double-blind clinical trial.
The emergency department of an urban children's hospital.
Children 1 year of age or older with a laceration </= 5 cm in length that required suturing. Intervention. A total of 240 children were randomly assigned to one of four treatment groups.
Pain felt during suturing was scored by suture technicians, research assistants, parents, and patients >/= 5 years of age using a visual analogue scale (VAS). Suture technicians, research assistants, and parents also scored pain using a seven-point Likert scale. In addition, suture technicians completed an anesthetic effectiveness scale.
There was consistently no difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. A statistically significant difference was seen among anesthetics when comparing VAS and Likert scale scores of suture technicians and Likert scale scores of research assistants. Based on post hoc analyses, these statistically significant differences were between TAC and prilocaine-phenylephrine (suture technician VAS and Likert scale) and between TAC and tetracaine-lidocaine-phenyl-ephrine (suture technician Likert scale), but not between TAC and tetraphen. When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 1.2 VAS units for each of the observer groups. Based on anesthetic effectiveness scale scores, the three new topical preparations collectively performed significantly better on the face and scalp than on the extremities (relative risk = 1.83; 95% confidence interval 1.20 < relative risk < 2.79).
This study demonstrated the effectiveness and safety of three new non-cocaine-containing topical anesthetics. Consistently, there was no statistical difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. Tetraphen offers an effective alternative to TAC during laceration repair in children.
比较三种不含可卡因的新型局部麻醉剂（丙胺卡因 - 去氧肾上腺素、丁卡因 - 去氧肾上腺素[丁四卡因]和丁卡因 - 利多卡因 - 去氧肾上腺素）与丁卡因 - 肾上腺素 - 可卡因（TAC）在儿童裂伤修复中的效果。
前瞻性、随机、双盲临床试验。
一家城市儿童医院的急诊科。
年龄在1岁及以上、裂伤长度≤5 cm且需要缝合的儿童。干预措施。总共240名儿童被随机分配到四个治疗组之一。
缝合过程中的疼痛由缝合技术人员、研究助理、家长以及5岁及以上的患者使用视觉模拟量表（VAS）进行评分。缝合技术人员、研究助理和家长还使用七点李克特量表对疼痛进行评分。此外，缝合技术人员完成一份麻醉效果量表。
在每个观察组的各项观察指标上，丁四卡因和TAC的效果始终没有差异。在比较缝合技术人员的VAS和李克特量表评分以及研究助理的李克特量表评分时，各麻醉剂之间存在统计学上的显著差异。根据事后分析，这些统计学上的显著差异存在于TAC与丙胺卡因 - 去氧肾上腺素之间（缝合技术人员的VAS和李克特量表）以及TAC与丁卡因 - 利多卡因 - 去氧肾上腺素之间（缝合技术人员的李克特量表），但TAC与丁四卡因之间不存在差异。当使用α = 0.05和β = 0.20进行效能分析时，每个观察组能够检测到1.2个VAS单位的差异。根据麻醉效果量表评分，三种新型局部制剂在面部和头皮上的总体表现明显优于四肢（相对风险 = 1.83；95%置信区间1.20 < 相对风险 < 2.79）。
本研究证明了三种新型不含可卡因的局部麻醉剂的有效性和安全性。在每个观察组的各项观察指标上，丁四卡因和TAC的效果始终没有统计学差异。在儿童裂伤修复过程中，丁四卡因是TAC的一种有效替代药物。
