Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial
Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial
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未产妇自行注射利多卡因凝胶用于宫内节育器置入：一项随机对照试验
DOI：
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发表时间：
2014
影响因子：
7.2
通讯作者：
Beatrice A. Chen
中科院分区：
文献类型：
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作者：
R. Rapkin;S. Achilles;E. Bimla Schwarz;Leslie A. Meyn;M. Cremer;Christy M. Boraas;Beatrice A. Chen
目的：探讨利多卡因凝胶阴道给药对未产妇放置宫内节育器(IUD)疼痛的影响。方法：在这项随机、双盲、安慰剂对照试验中，妇女在放置宫内节育器前5分钟自我注射2%利多卡因或安慰剂阴道凝胶。主要结果是疼痛从基线到放置宫内节育器在100 mm视觉模拟尺度上的变化。我们还评估了置入窥镜、放置支持带、子宫探查和放置宫内节育器5分钟后的疼痛。次要结果包括患者的可接受性、放置宫内节育器的容易程度以及最长7天的止痛药需求。结果：从2012年7月到2013年5月，59名女性被随机分组；30名接受利多卡因凝胶治疗，29名接受安慰剂治疗。基线人口统计数据，包括年龄、种族和体重指数，都是相似的。与安慰剂组(69 mm[四分位数范围63-80])相比，接受利多卡因(61 mm[四分位数范围53-71])的妇女在放置宫内节育器期间疼痛的中位数变化没有差别，P=0.06。与安慰剂(56 mm[四分位数范围26-75])相比，接受利多卡因治疗的女性在使用支持带时疼痛较少(32 mm[四分位数范围18-54]，P=0.02)。大多数(76%)女性对放置宫内节育器的体验感到满意，86%的女性可能或肯定会向朋友推荐宫内节育器。34%的女性在放置宫内节育器后至少需要3天的止痛药。结论：未产妇放置宫内节育器时，阴道自服利多卡因凝胶不能减轻放置宫内节育器时的疼痛，但可减少放置支持带时的疼痛。临床试验注册：ClinicalTrials.gov，http://clinicaltrials.gov，NCT01534520。
OBJECTIVE: To evaluate self-administration of vaginal lidocaine gel to decrease pain with intrauterine device (IUD) insertion in nulliparous women. METHODS: In this randomized, double-blind, placebo-controlled trial, women self-administered 2% lidocaine or placebo vaginal gel 5 minutes before IUD insertion. The primary outcome was change in pain from baseline to IUD insertion on a 100-mm visual analog scale. We also assessed pain after speculum insertion, tenaculum placement, uterine sounding, and 5 minutes after IUD insertion. Secondary outcomes included patient acceptability, ease of IUD insertion, and need for pain medication for up to 7 days. RESULTS: From July 2012 to May 2013, 59 women were randomized; 30 received lidocaine gel and 29 placebo. Baseline demographics, including age, race, and body mass index, were similar. There was no difference in median change in pain during IUD insertion in women receiving lidocaine (61 mm [interquartile range 53–71]) compared with placebo (69 mm [interquartile range 63–80], P=.06). Women receiving lidocaine experienced less pain with tenaculum placement (32 mm [interquartile range 18–54]) compared with placebo (56 mm [interquartile range 26–75], P=.02). Most (76%) women were satisfied with their IUD insertion experience and 86% would probably or definitely recommend an IUD to a friend. Thirty-four percent of women required pain medication for at least 3 days after IUD insertion. CONCLUSION: For nulliparous women, self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, but does decrease pain with tenaculum placement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01534520.