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Opioid Analgesia for MAB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03139240
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alyssa Colwill, 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.

Condition or disease Intervention/treatment Phase
MAB Pain Drug: Oxycodone 10mg oral Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Opioid Analgesia for MAB: A Randomized Controlled Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Maximum self-reported pain score on a numeric rating scale [ Time Frame: 24 hours after misoprostol administration ]
    Women will text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139240


Locations
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United States, Oregon
Site 1
Beaverton, Oregon, United States, 97005
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning

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Responsible Party: Alyssa Colwill, MD, Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03139240     History of Changes
Other Study ID Numbers: 16845
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents