Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain Control With IUD Insertion
研究概览
简要总结
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
详细描述
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.
The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
- •age 18 years and older
- •desiring Paragard or Mirena intrauterine device insertion
排除标准
- •Current pregnancy
- •cervical stenosis
- •severe medical illness
- •known allergy or sensitivity to lidocaine or naproxen
- •peptic ulcer disease
- •current pelvic inflammatory disease
- •patients with known renal insufficiency
- •patients using chronic NSAIDs or on chronic pain medication
- •women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC
研究组 & 干预措施
Naproxen/Normal saline
Patient will receive naproxen and intrauterine normal saline prior to IUD insertion
干预措施: Naproxen (Drug)
Placebo
Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion
干预措施: placebo (Drug)
Naproxen/Normal saline
Patient will receive naproxen and intrauterine normal saline prior to IUD insertion
干预措施: placebo (Drug)
Placebo oral medication/Lidocaine
Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion
干预措施: Lidocaine (Drug)
Placebo oral medication/Lidocaine
Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion
干预措施: placebo (Drug)
Naproxen/Lidocaine
Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
干预措施: Naproxen (Drug)
Naproxen/Lidocaine
Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
干预措施: Lidocaine (Drug)
结局指标
主要结局
Pain Control With IUD Insertion
时间窗: within 30 minutes after IUD insertion
visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain
次要结局
- Physician Perceived Pain Control During IUD Insertion(within 30 minutes after IUD insertion)
- Difficulty IUD Insertion(within 30 minutes of IUD insertion)
- Patient Satisfaction With IUD(30 days post insertion)
- Perceived Pain 30 Days Post Insertion(30 days post IUD insertion)