Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is:
- To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
- To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
- To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.
Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18 years or older
- •Premenopausal
- •Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla)
- •English-speaking or non-English speaking with appropriate translator available
排除标准
- •Currently pregnant or pregnant within the last 4 weeks
- •Not eligible for IUD insertion per PPLM's clinical protocols
- •Presenting for IUD removal and reinsertion
- •Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
- •Pain medications taken within 12 hours of enrollment
- •Misoprostol usage within 24 hours of enrollment
- •Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)
研究组 & 干预措施
Naproxen sodium
550 mg naproxen sodium
干预措施: Naproxen sodium (Drug)
Placebo
Placebo
干预措施: Placebo tablet (Other)
结局指标
主要结局
Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
时间窗: Immediately after IUD insertion is complete
Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
次要结局
- Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)(Immediately after tenaculum is placed on cervix)
- Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)(Fifteen minutes after IUD insertion is complete)
- Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)(Immediately after uterine sounding)
- Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)(Five minutes after IUD insertion is complete)