Opioid Analgesia for MAB

Study Overview
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Brief Summary
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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
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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.

Official Title
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Opioid Analgesia for MAB: A Randomized Controlled Trial

Conditions
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MAB, Pain

Intervention / Treatment
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* Drug: Oxycodone 10mg oral
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gestational age <7 weeks<br>Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo | Drug: Oxycodone 10mg oral<br>* Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion<br>Other: Placebo<br>* Placebo given in addition to standard of care medications in women undergoing medical abortion<br>|
| Experimental: Gestational age 7-10w0d<br>Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo | Drug: Oxycodone 10mg oral<br>* Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion<br>Other: Placebo<br>* Placebo given in addition to standard of care medications in women undergoing medical abortion<br>|

What is the study measuring?
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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 |