Double-blind, Randomized, Placebo-controlled Study on the Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing Intrauterine System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- VAS (Visual Analog Score) pain score
研究概览
简要总结
Does the addition of cervical lidocaine injections and valium to the current practice result in decreased reported pain with tenaculum placement, IUD insertion, and post procedural discomfort? The current practice is ibuprofen alone or no medication.
详细描述
Long acting reversible contraception, including intrauterine devices (IUDs), provide birth control for an extended period of time. IUDs are the most effective type of reversible birth control for women who do not wish to become pregnant over the next couple years, have the lowest failure rate (Winner, 2012), and in 2007, were used by more than 180 million women worldwide (Darney, 2010). Despite the high efficacy and low rates of side effects, women may decline placement of an IUD due to fear of pain associated with placement. IUDs may act as a barrier to women selecting this method of contraception. Currently there is no consensus in the literature as to the most effective way to address analgesia surrounding IUD insertion.
In order to eliminate barriers to selecting the IUD for contraception, improve the experience of women undergoing placement, and standardize local practices, investigators want to investigate analgesic options affecting patients' perception of pain during the various steps of IUD insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age,
- •Desires to undergo placement of a levonorgestrel containing intrauterine device
排除标准
- •Device manufacturer contraindications such as signs of genital infection, positive urine pregnancy test, abnormal vaginal bleeding, abnormal sized uterus that sounds <6cm or >10cm, and all other contraindications to placement of a levonorgestrel containing IUD.
- •Patients with a history of drug abuse.
- •History of a prior IUD
- •Current use of medications for anxiety
- •Also, a diagnosis of chronic pain.
研究组 & 干预措施
Control
Control arm receives ibuprofen, placebo pill, and placebo injection.
干预措施: Placebo pill (Other)
Control
Control arm receives ibuprofen, placebo pill, and placebo injection.
干预措施: Placebo injection (Other)
Treatment
Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.
干预措施: Diazepam (Drug)
Treatment
Treatment arm receives ibuprofen, diazepam pill, and lidocaine injection.
干预措施: Lidocaine (Drug)
结局指标
主要结局
VAS (Visual Analog Score) pain score
时间窗: At IUD insertion
次要结局
未报告次要终点