OPIOID Study: Opioid Use and Pain After Insertion of Osmotic Dilators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Maximum pain above baseline following Laminaria versus Dilapan-S placement
研究概览
简要总结
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
详细描述
This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D&E) procedures. Pain levels and medication usage will also be assessed following the D&E procedure itself, up to 7 days after the procedure.
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
- Single (Participant)
盲法说明
Participants will not know what type of dilator they have been assigned, however the medical care team (including investigators) will be aware.
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
- •scheduled D&E for 15+0 to 23+6 wga
- •ability to speak and read in English
- •ownership of smartphone with internet access and data plan
排除标准
- •chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics
结局指标
主要结局
Maximum pain above baseline following Laminaria versus Dilapan-S placement
时间窗: First 24 hours after dilator placement
Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement
Time of maximum pain above baseline following Laminaria versus Dilapan-S placement
时间窗: First 24 hours after dilator placement
Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement
次要结局
- Pain medication use after D&E(First week after D&E)
- Pain medication use after Laminaria versus Dilapan-S placement(First 24 hours after dilator placement)
- Maximum pain increase over baseline following D&E procedure(First week after D&E)