Opioid Analgesia for MAB

Phase 4

Completed

• Conditions: Pain; MAB
• Interventions: Drug: Oxycodone 10mg oral; Other: Placebo

• Registration Number: NCT03139240
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Study Timeline

• Study First Submitted: 2017-04-28
• Study Start: 2017-05-01
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Results First Submitted: 2019-06-06
• Results First Submitted QC: 2019-07-26
• Status Verified: 2019-08
• Results First Posted: 2019-08-13
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gestational age <7 weeks	Placebo	Women with a gestational age \<7 weeks will be randomized to oxycodone 10mg oral vs placebo
Gestational age 7-10w0d	Oxycodone 10mg oral	Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo
Gestational age <7 weeks	Oxycodone 10mg oral	Women with a gestational age \<7 weeks will be randomized to oxycodone 10mg oral vs placebo
Gestational age 7-10w0d	Placebo	Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo

Primary Outcome Measures

Name	Time	Method
<7 Weeks of Gestation - Maximum Self-reported Pain Score	24 hours after misoprostol administration	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
7-10 Weeks Gestation - Maximum Self-reported Pain Score	24 hours after misoprostol administration	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).
Overall Maximum Self-reported Pain Score	24 hours after misoprostol administration	Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).

Trial Locations

Locations (1)

Site 1; 🇺🇸 Beaverton, Oregon, United States