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Clinical Study

Different analgesics prior to intrauterine device insertion: is there any evidence of efficacy?

&
Pages 222-226
Received 27 Jan 2017
Accepted 05 Apr 2017
Published online: 02 May 2017

Abstract

Objectives: The aims of this study were to compare three different interventions to reduce pain related to insertion of the intrauterine device (IUD), namely, lidocaine, misoprostol and a non-steroidal anti-inflammatory drug, against a placebo, and to assess the advantages of one drug over another, if any.

Methods: This was an open-label randomised placebo-controlled trial of 200 women assigned to receive one of the following medications prior to IUD insertion: 10 ml 1% lidocaine paracervical block, 400 μg oral misoprostol, oral naproxen or placebo tablets. The primary outcome measure was the level of pain experienced at different steps of IUD insertion and 15 min after the procedure, measured by a visual analogue scale (VAS).

Results: Between July 2015 and March 2016, 208 women were invited to participate in the study: eight refused and the remaining 200 women were randomised equally into four treatment groups (50 participants in each group). All characteristics were similar between the groups. The mean pain scores recorded during speculum placement, tenaculum application, uterine sounding, IUD insertion and 15 min after insertion were similar among the four groups (p > .05). Adjuvant methods to facilitate insertion, insertion failure or device expulsion were similar between the groups (p > .05). Complications were reported in 17 participants (8.5%); all resolved spontaneously with no further management (p > .05).

Conclusion: Despite finding that none of the study drugs seemed effective prior to IUD insertion, insertion did not cause severe pain. The negative findings indicate the need for future research into new strategies to decrease pain during IUD placement.

Chinese abstract

目的:本研究的目的是比较三种不同的干预措施对宫内节育器(IUD)置入相关疼痛的减轻作用, 即利多卡因, 米索前列醇、非甾体抗炎药与安慰剂的比较, 如果有差别则评估一种药物相比于另一种药物的优势。

方法:这是一项开放式随机安慰剂临床试验, 在宫内节育器置入之前分配给200名妇女以下药物之一:10ml 1%利多卡因宫颈旁阻滞, 400μg口服米索前列醇, 口服萘普生或安慰剂片。 主要结局测量指标是宫内节育器置入不同步骤及术后15分钟的疼痛水平, 通过视觉模拟量表(VAS)测量。

结果:2015年7月至2016年3月期间, 208名女性受邀参加本研究:8人拒绝参加, 剩余的200名妇女随机分为4个治疗组(每组50人)。各组之间的所有指征相似。在使用窥器, 应用宫颈钳, 子宫探查, 宫内节育器置入及置入后15分钟记录的平均疼痛评分四组相似(p> 0.05)。各组之间有利于置入, 置入失败或装置移出的辅助方法相似(p> 0.05)。有17名参与者报道了并发症(8.5%);所有人员都是自然痊愈, 没有进行进一步管理(p> 0.05)。

结论:尽管在宫内节育器置入前使用参与研究的药物似乎均无效, 但置入过程并没有引起剧烈的疼痛。阴性结果表明, 今后需要探索能减轻宫内节育器放置期间疼痛的新策略。

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the text.

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