Phase 4
Completed N=172
Opioid Analgesia for MAB
MAB · Postoperative Pain
Source: ClinicalTrials.gov NCT03139240 ↗
Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Overall Maximum Self-reported Pain Score — 8; 8 units on a scale
◆ Published Evidence
Established
32citations · ~5 / year
Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.
Summary
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.
Linked Publications
-
Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Maximum Self-reported Pain Score |
8; 8 | — |
| PRIMARY <7 Weeks of Gestation - Maximum Self-reported Pain Score |
8; 8 | — |
| PRIMARY 7-10 Weeks Gestation - Maximum Self-reported Pain Score |
9; 8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03139240) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.