Opioid Analgesia for MAB
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/22/2018 |
| Start Date: | May 1, 2017 |
| End Date: | May 31, 2018 |
Opioid Analgesia for MAB: A Randomized Controlled Trial
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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