Sarkarat Farzin, Naeini Marzie, Kahali Roozbeh, Sezavar Mehdi, Rakhshan Vahid
Department of Oral and Maxillofacial Surgery, Gulf Medical University, Ajman, United Arab Emirates.
Private Practice in Dentistry, Tehran, Iran.
J Oral Biol Craniofac Res. 2025 Nov-Dec;15(6):1473-1478. doi: 10.1016/j.jobcr.2025.09.001. Epub 2025 Sep 6.
Pain and complications of botulinum toxin injection are important deterrents that may reduce patient satisfaction. Toxin attenuation via lidocaine (with or without epinephrine) might alleviate pain. Except a recent study, no study has assessed the effects of the incorporation of lidocaine alone (without epinephrine/additives) to botulinum toxin.
This pilot multicenter double-blind randomized placebo-controlled clinical trial was performed on 102 patients randomly divided into two groups of experimental (lidocaine without epinephrine) or control (normal saline). Patients received 100 units of botulinum toxin. In the experimental group, botulinum toxin was diluted with 1 ml of 2 % lidocaine without adrenalin; in the placebo group, botulinum toxin was diluted with 1 ml of normal saline. Pain was assessed after injection using a 11-point numerical rating scale '0-10'. Post-injection complications were assessed 24 h later based on patients' reports and surgeons' observations. Data were analyzed using Student t-test and Fisher exact test (α = 0.05).
The groups were balanced in terms of age and gender ( > 0.05). The mean (SD) pain levels in the placebo and lidocaine groups were 3.70 ± 2.05 and 3.39 ± 1.78, respectively ( = 0.310, -test). Ptosis and diplopia were not observed in any groups. Asymmetry existed in 4 control subjects (8.7 %) and 5 experimental subjects (8.9 %) ( = 1.0, Fisher). In the control group, 12 patients needed retouch treatment (26.1 %); in the lidocaine group, 11 patients needed retouch therapy (19.6 %) (Fisher, = 0.482).
Dilution of botulinum toxin with lidocaine might not reduce injection pain or alter the incidence of the assessed complications after 24 h.
肉毒杆菌毒素注射引起的疼痛和并发症是重要的阻碍因素，可能会降低患者满意度。通过利多卡因（含或不含肾上腺素）减轻毒素作用可能会缓解疼痛。除了最近的一项研究外，尚无研究评估单独使用利多卡因（不含肾上腺素/添加剂）与肉毒杆菌毒素混合的效果。
这项初步的多中心双盲随机安慰剂对照临床试验对102例患者进行，这些患者被随机分为两组，实验组（不含肾上腺素的利多卡因）或对照组（生理盐水）。患者接受100单位肉毒杆菌毒素。在实验组中，肉毒杆菌毒素用1毫升2％不含肾上腺素的利多卡因稀释；在安慰剂组中，肉毒杆菌毒素用1毫升生理盐水稀释。注射后使用11点数字评分量表“0-10”评估疼痛。注射24小时后根据患者报告和外科医生观察评估注射后并发症。数据采用学生t检验和Fisher精确检验进行分析（α=0.05）。
两组在年龄和性别方面均衡（>0.05）。安慰剂组和利多卡因组的平均（标准差）疼痛水平分别为3.70±2.05和3.39±1.78（=0.310，t检验）。两组均未观察到上睑下垂和复视。对照组有4名受试者（8.7％）和实验组有5名受试者（8.9％）存在不对称（=1.0，Fisher检验）。对照组中有12名患者需要进行补打治疗（26.1％）；利多卡因组中有11名患者需要进行补打治疗（19.6％）（Fisher检验，=0.482）。
用利多卡因稀释肉毒杆菌毒素可能不会减轻注射疼痛，也不会改变24小时后评估的并发症发生率。
