NCT03139240

Opioid Analgesia for MAB

Opioid Analgesia for MAB: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• MAB
• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone 10mg oral	Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
OTHER	Placebo	Placebo given in addition to standard of care medications in women undergoing medical abortion

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-05-03
• Last updated: 2019-08-28
• Results posted: 2019-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study