Opioid Analgesia for MAB: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- <7 Weeks of Gestation - Maximum Self-reported Pain Score
研究概览
简要总结
Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.
详细描述
This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.
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
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •Seeking elective medical abortion
- •In good health
- •Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
- •Able and willing to receive text messages via phone
- •Literate in English
- •Able and willing to give informed consent and agree to the study terms
- •Have assistance at home; no motor vehicle use while taking study medications
排除标准
- •Lack of access to cell phone and texting capabilities
- •Early pregnancy failure
- •Contraindications to the study medications: Oxycodone, Ibuprofen
- •Contraindications to medical abortion with Mifepristone or Misoprostol
- •History of methadone or heroin use
- •Used alcohol in the past 24 hours
- •Used marijuana >4 times per week
- •Any opioid in the past 30 days
- •Using additional pain medications
研究组 & 干预措施
Gestational age <7 weeks
Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo
干预措施: Oxycodone 10mg oral (Drug)
Gestational age <7 weeks
Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo
干预措施: Placebo (Other)
Gestational age 7-10w0d
Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo
干预措施: Oxycodone 10mg oral (Drug)
Gestational age 7-10w0d
Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo
干预措施: Placebo (Other)
结局指标
主要结局
<7 Weeks of Gestation - Maximum Self-reported Pain Score
时间窗: 24 hours after misoprostol administration
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
7-10 Weeks Gestation - Maximum Self-reported Pain Score
时间窗: 24 hours after misoprostol administration
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Overall Maximum Self-reported Pain Score
时间窗: 24 hours after misoprostol administration
Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
次要结局
未报告次要终点
研究者
Alyssa Colwill
MD, Instructor
Oregon Health and Science University