Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, DC, USA. matthew.kuhnle@us
J Cataract Refract Surg. 2011 Feb;37(2):364-9. doi: 10.1016/j.jcrs.2010.08.041.
To compare the efficacy of oral gabapentin versus placebo for the control of severe pain after photorefractive keratectomy (PRK).
Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, DC, USA.
Randomized masked clinical trial.
This single-center clinical trial comprised active-duty United States Army soldiers aged 21 years or older having bilateral PRK for myopia with or without astigmatism. Patients received gabapentin 300 mg or placebo 3 times daily for 7 days beginning 2 days before and continuing for 4 days after surgery. Current and maximum pain levels were assessed using the Visual Analog Pain scale 2 hours after surgery and then daily on days 1 through 4. Repeated-measures analysis of variance (ANOVA) was used to compare the current and maximum pain scores over time between the gabapentin group and the placebo group. The Fisher exact test was used to determine whether there was a difference in severe pain (>7/10) between the 2 groups.
Forty-two patients received gabapentin and 41 patients, placebo. The repeated-measures ANOVA showed no significant difference between the 2 groups in current pain (P = .84) or in maximum pain over time (P = .35). Oxycodone-acetaminophen use in the gabapentin group was significantly higher than in the placebo group 1 day postoperatively (P = .034).
When added to a standardized postoperative pain regimen, gabapentin use led to no additional improvement in PRK pain control compared with a placebo at the dose and the time intervals tested.
比较口服加巴喷丁与安慰剂在控制光折射性角膜切削术(PRK)后重度疼痛的疗效。
美国华盛顿特区沃尔特里德陆军医疗中心屈光手术中心。
随机、双盲临床试验。
本单中心临床试验纳入年龄在 21 岁及以上的现役美国陆军士兵,双眼均因近视伴或不伴散光行 PRK 手术。患者于术前 2 天开始每日口服加巴喷丁 300 mg 或安慰剂 3 次,共 7 天,术后 4 天持续服用。术后 2 小时使用视觉模拟疼痛量表评估当前和最大疼痛水平,然后在术后第 1 天至第 4 天每天评估。采用重复测量方差分析(ANOVA)比较加巴喷丁组和安慰剂组在不同时间点的当前和最大疼痛评分。采用 Fisher 确切概率法比较两组重度疼痛(>7/10)的发生率是否存在差异。
42 例患者接受加巴喷丁治疗,41 例患者接受安慰剂治疗。重复测量方差分析显示,两组患者的当前疼痛(P =.84)或最大疼痛随时间的变化(P =.35)均无显著差异。术后第 1 天,加巴喷丁组使用羟考酮-对乙酰氨基酚的比例显著高于安慰剂组(P =.034)。
在标准化术后疼痛管理方案的基础上,加巴喷丁治疗并未改善 PRK 术后疼痛控制,与本研究中使用的剂量和时间间隔相关。