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Completed

NCT Number: NCT03139240

Opioid Analgesia for MAB

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.

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Key information

Conditions

MAB Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Site 1

Beaverton, Oregon, 97005, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone 10mg oral

Drug

Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion

Placebo

Other

Placebo given in addition to standard of care medications in women undergoing medical abortion

Primary outcomes

  1. Overall Maximum Self-reported Pain Score

    Time frame: 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).

  2. <7 Weeks of Gestation - Maximum Self-reported Pain Score

    Time frame: 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).

  3. 7-10 Weeks Gestation - Maximum Self-reported Pain Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Opioid Analgesia for MAB: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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