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临床试验/NCT03870711
NCT03870711已完成4 期

10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
124
试验地点
1
主要终点
Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale

研究概览

简要总结

Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

详细描述

Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman who required for Copper T IUD insertion
  • Body mass index 18.5 - 30 kg/m2
  • Communicable with Thai language
  • New IUD user

排除标准

  • Suspicion of pregnancy
  • Puerperal sepsis/Immediate post-septic abortion
  • Untreated abnormal uterine bleeding
  • Uterine anomaly/abnormal pathology distorting the uterine cavity
  • Current pelvic inflammatory disease
  • Untreated cervicitis/vaginitis
  • Wilson's disease
  • Copper allergy
  • known hypersensitivity to local anaesthetic
  • Analgesic or anxiolytic use within the last 24 h before the procedure

研究组 & 干预措施

group A

Experimental

10% lidocaine spray

干预措施: lidocaine spray (Drug)

group B

Placebo Comparator

sterile water

干预措施: Placebo (Drug)

结局指标

主要结局

Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale

时间窗: Immediately after the procedure

Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

次要结局

  • Side effects of 10% Lidocaine spray(20 minutes after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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