Opioid Analgesia for MAB

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: MAB; Pain

Treatments: Other: Placebo; Drug: Oxycodone 10mg oral

Study type: Interventional

Funder types: Other

Identifiers

NCT03139240

16845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

172 participants in 2 patient groups

Gestational age <7 weeks

Experimental group

Description:

Women with a gestational age \<7 weeks will be randomized to oxycodone 10mg oral vs placebo

Treatment:

Drug: Oxycodone 10mg oral

Other: Placebo

Gestational age 7-10w0d

Experimental group

Description:

Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo

Treatment:

Drug: Oxycodone 10mg oral

Other: Placebo