Cannabinoids for Pain Control During Medical Abortion
关键词
抽象
描述
This is a randomized, double-blind, placebo-controlled trial comparing pain levels in women undergoing medical abortion with one of two regimens: ibuprofen 800mg and a 5mg oral dronabinol versus ibuprofen 800mg and placebo given at the time of misoprostol administration. This study will include 62 women undergoing medical abortion. Women will be randomized to dronabinol 5mg oral versus placebo. The primary outcome will be maximum reported pain score within 24 hours of misoprostol administration.
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 07/18/2018 |
| 提交的预估入学人数: | 07/18/2018 |
| 首次发布: | 07/26/2018 |
| 上次提交的更新: | 03/23/2020 |
| 最近更新发布: | 04/06/2020 |
| 首次提交结果的日期: | 03/23/2020 |
| 首次提交质量检查结果的日期: | 03/23/2020 |
| 首次发布结果的日期: | 04/06/2020 |
| 实际学习开始日期: | 10/31/2018 |
| 预计主要完成日期: | 05/06/2019 |
| 预计完成日期: | 05/27/2019 |
状况或疾病
干预/治疗
Drug: Gestational age up to 10w0d - Dronabinol
Other: Gestational age up to 10w0d - Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Gestational age up to 10w0d - Dronabinol Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo | Drug: Gestational age up to 10w0d - Dronabinol Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain |
| Placebo Comparator: Gestational age up to 10w0d - Placebo Women with gestational age up to 10 weeks 0 days will be randomized to Dronabinol 5mg Cap or placebo | Other: Gestational age up to 10w0d - Placebo Subjects randomized to placebo and ibuprofen 800mg for pain |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Aged 21 years or older - Consented for elective medical abortion - Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound - Able and willing to receive text messages via phone - English speaking - 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 Exclusion Criteria: - Desires to continue pregnancy or currently breastfeeding - Lack of access to cell phone and texting capabilities - Prior participation in this study - Early pregnancy failure - Contraindications to the study medications: Marinol or marijuana derivatives, sesame oil, Ibuprofen - Contraindications to medical abortion with Mifepristone or Misoprostol - History of methadone, buprenorphine or heroin use within the last year - History of a seizure disorder - Used marijuana 5 or more days in the last week - History of any adverse effects associated with prior use of recreational or medical marijuana products, or sensitivity/allergy to Marinol. |
结果
主要结果指标
1. Maximum Self-reported Pain Score on a Numeric Rating Scale [24 hours after misoprostol administration]
