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临床试验/NCT03031795
NCT03031795已完成4 期

Oral Ketorolac for Pain Relief During IUD Insertion: A Randomized Controlled Trial

OhioHealth0 个研究点目标入组 71 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
OhioHealth
入组人数
71
主要终点
Pain Before, During and After IUD Placement

研究概览

简要总结

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.

详细描述

In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a 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
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

入选标准

  • non-pregnant
  • English speaking women
  • 18 years of age or older desiring an IUD for contraception

排除标准

  • enrollment in another study
  • pre-medication with any type of analgesic medication
  • contraindication to an IUD
  • weight under 50 kg
  • allergy to non-steroidal anti-inflammatory medications
  • past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed,
  • daily narcotic pain use
  • positive cultures for gonorrhea or chlamydia.

研究组 & 干预措施

experimental

Experimental

ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

干预措施: Ketorolac (Drug)

placebo

Placebo Comparator

look alike placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Pain Before, During and After IUD Placement

时间窗: Before, during and after IUD placement

Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.

次要结局

未报告次要终点

研究者

发起方
OhioHealth
申办方类型
Other
责任方
Sponsor

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