Phase 4 N=172 Randomized Double-blind Treatment

Opioid Analgesia for MAB

MAB · Pain

Bottom Line

View on ClinicalTrials.gov: NCT03139240 ↗

Enrolled (actual)

172

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Overall Maximum Self-reported Pain Score — 8; 8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Oxycodone 10mg oral (Drug); Placebo (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: May 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03139240). 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.