Opioid Analgesia for MAB

Opioid Analgesia for MAB: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; MAB
• Intervention / Treatment: Drug: Oxycodone 10mg oral; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Beaverton, Oregon, United States, 97005
      • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gestational age <7 weeks; Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo	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
Experimental: Gestational age 7-10w0d; Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Maximum Self-reported Pain Score	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).	24 hours after misoprostol administration
<7 Weeks of Gestation - Maximum Self-reported Pain Score	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).	24 hours after misoprostol administration
7-10 Weeks Gestation - Maximum Self-reported Pain Score	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).	24 hours after misoprostol administration

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Society of Family Planning

Publications and helpful links

General Publications

• Colwill AC, Bayer LL, Bednarek P, Garg B, Jensen JT, Edelman AB. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1163-1170. doi: 10.1097/AOG.0000000000003576.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 16845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No