Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR 97239, USA.
Contraception. 2013 Apr;87(4):421-5. doi: 10.1016/j.contraception.2012.10.030. Epub 2012 Dec 4.
Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroprusside gel applied intracervically prior to IUD placement would reduce insertion-related pain.
We performed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 10-mg nitroprusside gel (1 mL) or identical placebo gel applied intracervically in nulliparous women immediately prior to IUD placement. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with IUD insertion. Secondary outcomes included provider-reported ease of insertion, subject-reported pain at other time points, side effects, adverse events and need for additional dilation.
A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 73 mm (SD 17 mm) in the placebo group and 59 mm (SD 26 mm) in the nitroprusside group (p=.15). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group. There were two vasovagal reactions in the nitroprusside group and none in the placebo group.
Intracervical administration of 10-mg nitroprusside gel immediately prior to IUD insertion does not appear to provide a clinically relevant improvement in patient-reported pain with IUD insertion among nulliparous women.
对宫内节育器(IUD)放置过程中疼痛的担忧是其使用的障碍,尤其是对未生育的女性而言。我们假设在放置 IUD 之前在宫颈内应用硝普钠凝胶会减轻与放置相关的疼痛。
我们进行了一项随机、双盲、安慰剂对照的初步研究,以评估 10mg 硝普钠凝胶(1ml)或相同的安慰剂凝胶在放置 IUD 前即刻在宫颈内应用对未生育的女性的疗效和耐受性。受试者在多个时间点完成了一系列 100mm 视觉模拟量表。主要结局是受试者报告的 IUD 插入相关疼痛。次要结局包括提供者报告的插入容易程度、受试者报告的其他时间点的疼痛、副作用、不良事件和需要额外扩张的情况。
共有 24 名女性被随机分配。两组间的基线特征相似。安慰剂组的 IUD 部署时平均疼痛评分为 73mm(SD 17mm),硝普钠组为 59mm(SD 26mm)(p=.15)。提供者报告的插入容易程度没有差异。有两名受试者需要扩张,每组各一名。硝普钠组有两名血管迷走神经反应,安慰剂组没有。
在放置 IUD 之前,宫颈内应用 10mg 硝普钠凝胶似乎并不能为未生育的女性提供 IUD 插入相关疼痛的患者报告的疼痛改善。