Vaginal dinoprostone versus placebo for pain relief during intrauterine device insertion: a systematic review and meta-analysis of randomised controlled trials

Abstract

Objective

To systematically and meta-analytically investigate the efficacy and safety of vaginal dinoprostone versus placebo in pain relief during intrauterine device (IUD) insertion.

Methods

PubMed, Scopus, Web of Science, and Cochrane Library were screened till 1 October 2020. Only randomised placebo-controlled studies were included and assessed for risk of bias. Main outcomes included IUD insertion related pain, patient satisfaction, provider ease of IUD insertion, and side effects. Pooled outcomes were summarised as standardised mean difference (SMD), weighted mean difference (WMD), or risk ratio (RR) with 95% confidence interval (95% CI).

Results

Five studies were included, comprising 862 patients; equally 431 patients received vaginal dinoprostone and placebo. All studies showed an overall low risk of bias. When compared to placebo, dinoprostone significantly correlated with decreased pain at tenaculum placement (SMD = −0.79, 95% CI [−1.43, −0.16], p = 0.01), decreased pain at uterine sounding (SMD = −0.88, 95% CI [−1.54, −0.22], p = 0.009), decreased pain at IUD insertion (SMD = −1.18, 95% CI [−1.74, −0.61], p < 0.001), decreased need for additional analgesia (RR = 0.34, 95% CI [0.22, 0.53], p < 0.001), increased patient satisfaction (SMD = 1.41, 95% CI [0.62, 2.20], p < 0.001), and increased provider ease of IUD insertion (SMD = −1.17, 95% CI [−1.62, −0.73], p < 0.001). Fever was statistically significantly higher in dinoprostone versus placebo group (RR = 3.73, 95% CI [1.47, 9.44], p = 0.006). All other side effects—including nausea, vomiting, shivering, diarrhoea, abdominal cramps, vasovagal attack, uterine perforation, and postprocedural bleeding—did not substantially differ between both groups.

Conclusions

This first ever meta-analysis advocates that dinoprostone compared with placebo is safe, effective, and yields favourable analgesic outcomes during IUD insertion.

阴道用地诺前列酮与安慰剂用于宫内节育器放置时疼痛缓解比较:一项随机对照试验的系统回顾和meta分析 摘要

目的：通过系统和meta分析比较阴道用地诺前列酮与安慰剂用于宫内节育器(IUD)放置时疼痛缓解的有效性和安全性。

方法： PubMed、Scopus、Web of Science、Cochrane图书馆进行检索, 截止2020年10月1日。仅纳入随机安慰剂对照研究, 并对偏倚风险进行了评估。主要结局包括与放置宫内节育器相关的疼痛、患者满意度、术者放置IUD的简便性以及副反应。合并结果总结为标准化均数差(SMD)、加权均数差(WMD)或风险比(RR)的 95%可信区间。

结果：纳入5项研究, 包括862名患者；431名患者接受阴道地诺前列酮和安慰剂治疗。所有研究总体上偏倚风险低。与安慰剂相比, 地诺前列酮与钳夹放置时的疼痛减轻显著相关(SMD＝-0.79, 95%CI[-1.43, -0.16], P=0.01), 减少了宫腔探查时的疼痛(SMD=-0.88, 95%CI[-1.54, -0.22], p=0.009), 减少了放置宫内节育器时的疼痛(SMD=-1.18, 95%CI[-1.74, -0.61], p<0.001), 减少了对额外镇痛的需求(RR=0.34, 95% CI [0.22, 0.53], p<0.001), 患者满意度提高(SMD=1.41, 95%CI[0.62, 2.20], P<0.001)；术者更容易放置宫内节育器(SMD=1.17, 95%CI[-1.62, -0.73], P<0.001)。地诺前列酮组的发热明显高于安慰剂组(RR=3.73, 95%CI[1.4 7, 9.44], P=0.006)。所有其他副反应-包括恶心、呕吐、寒战、腹泻、腹部绞痛、血管迷走性反射、子宫穿孔和术毕出血-在两组之间没有实质性差异。

结论：首次meta分析表明：与安慰剂相比, 地诺前列酮安全、有效, 并且在放置IUD时有良好的止痛效果。

Keywords:

• Dinoprostone
• placebo
• pain relief
• intrauterine device

Author contributions

AA contributed to study design, study conception, data analysis and manuscript writing. MSA, NAA, NTM, MA, SAA, AB-1, NA, AB-2, OA, HS, IAA and SB contributed to data collection and manuscript revision. All authors revised manuscript for editorial and intellectual contents. All authors read and approved the final draft of manuscript and agreed to be held responsible for data integrity.

Disclosure statement

No potential conflict of interest was reported by the author(s).