The Emergency Department, Southland Hospital, Invercargill, New Zealand.
Acad Emerg Med. 2014 Apr;21(4):374-82. doi: 10.1111/acem.12346.
The objective of this study was to test the hypothesis that topical tetracaine would be safe to use for 24 hours and would not affect corneal healing, that patients would experience more pain relief, and that patients would perceive tetracaine to be more effective than saline eye drops for the treatment of pain caused by corneal abrasions.
The study was a 12-month, prospective, double-blind, randomized trial of tetracaine versus saline set in the emergency department (ED) of a regional tertiary care teaching hospital. A total of 116 patients presenting with uncomplicated corneal abrasions were included in this study. The intervention was either undiluted, preservative-free, topical tetracaine hydrochloride 1% or saline, applied up to every 30 minutes while awake for 24 hours. Main safety outcome measures were repeat ED examinations at 48 hours with fluorescein staining and slit-lamp examination, 1-week and 1-month telephone interviews with additional examinations as needed, and monitoring of charts for complications. Secondary outcome measures were 100-mm visual analogue scale (VAS) pain scores recorded every 2 hours while awake for 48 hours and patient-perceived overall effectiveness using a numeric rating scale (NRS) of 0 to 10 obtained during telephone interviews.
At least one follow-up encounter was completed on each of the 116 patients. No complications specifically attributed to topical anesthetic use occurred in the 59 patients in the tetracaine group, and the binomial probability confidence interval (CI) of this occurring is 0 to 6.1. There was no significant difference in corneal healing as measured by the percentage of patients with persistent fluorescein uptake at 48 hours between the two groups (23.9% vs. 21.3%, difference=2.6%, 95% CI=-14% to 20%, p=0.761) or persistent symptoms at 48 hours (21.7% vs. 21.3%, difference=0.4%, 95% CI=-16% to 17%, p=0.957). There was no clinical difference in VAS pain scores between the groups. Patients in the tetracaine group rated the study drugs' overall effectiveness significantly higher on the NRS (7.7 vs. 3.9) compared to patients in the saline group (difference=3.9, 95% CI=2.4 to 5.3, p<0.0005).
Topical tetracaine used for 24 hours is safe, and while there was no significant difference in patient VAS pain ratings over time, patient surveys on overall effectiveness showed that patients perceived tetracaine to be significantly more effective than saline.
本研究旨在验证以下假设,即局部使用盐酸丁卡因 24 小时是安全的,不会影响角膜愈合,患者将获得更多的疼痛缓解,并且患者将认为丁卡因比生理盐水滴眼剂更有效地治疗角膜擦伤引起的疼痛。
本研究为为期 12 个月的前瞻性、双盲、随机试验,在一家地区性三级保健教学医院的急诊科比较了丁卡因与生理盐水。共纳入 116 例单纯性角膜擦伤患者。干预措施为使用未稀释的、无防腐剂的 1%盐酸丁卡因或生理盐水,在清醒时每 30 分钟使用一次,持续 24 小时。主要安全性结局指标为在第 48 小时用荧光素染色和裂隙灯检查进行重复急诊检查,在第 1 周和第 1 个月进行电话访谈,并根据需要进行额外检查,以及监测图表以了解并发症情况。次要结局指标为在第 48 小时内每 2 小时记录 100mm 视觉模拟量表(VAS)疼痛评分,在电话访谈期间使用 0 到 10 的数字评定量表(NRS)记录患者对整体疗效的主观感受。
在 116 例患者中,至少有 116 例完成了至少一次随访。在使用丁卡因的 59 例患者中,没有出现任何特定归因于局部麻醉剂使用的并发症,丁卡因组发生这种情况的二项概率置信区间(CI)为 0 到 6.1。两组患者在第 48 小时时仍有荧光素摄取的患者比例(23.9% vs. 21.3%,差异=2.6%,95%CI=-14%至 20%,p=0.761)或第 48 小时时仍有症状的患者比例(21.7% vs. 21.3%,差异=0.4%,95%CI=-16%至 17%,p=0.957)之间没有显著差异。两组患者的 VAS 疼痛评分没有临床差异。与生理盐水组患者相比,丁卡因组患者在 NRS 上对研究药物的整体疗效评价显著更高(7.7 分 vs. 3.9 分)(差异=3.9,95%CI=2.4 至 5.3,p<0.0005)。
局部使用盐酸丁卡因 24 小时是安全的,虽然患者的 VAS 疼痛评分随时间没有显著差异,但患者对整体疗效的调查显示,患者认为丁卡因比生理盐水更有效。