MAB, Pain
Conditions
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.
Interventions
DRUGOxycodone 10mg oral
Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
OTHERPlacebo
Placebo given in addition to standard of care medications in women undergoing medical abortion
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| <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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone: <7 Weeks Gestational Age Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to oxycodone 10mg oral | 48 |
| Placebo: <7 Weeks Gestational Age Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age \<7 weeks randomized to placebo | 48 |
| Oxycodone: 7-10w0d Weeks Gestational Age Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to oxycodone 10mg oral | 38 |
| Placebo: 7-10w0d Weeks Gestational Age Placebo: Placebo given in addition to standard of care medications in women undergoing medical abortion
Women with a gestational age 7-10w0d randomized to placebo | 38 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Oxycodone: <7 Weeks Gestational Age | Placebo: <7 Weeks Gestational Age | Oxycodone: 7-10w0d Weeks Gestational Age | Placebo: 7-10w0d Weeks Gestational Age | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 48 Participants | 38 Participants | 38 Participants | 172 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 21 Participants | 13 Participants | 24 Participants | 79 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 27 Participants | 27 Participants | 25 Participants | 14 Participants | 93 Participants |
| Region of Enrollment United States | 48 participants | 48 participants | 38 participants | 38 participants | 172 participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 38 Participants | 38 Participants | 172 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 86 |
| other Total, other adverse events | 4 / 86 | 2 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 |
Outcome results
Primary
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).
Time frame: 24 hours after misoprostol administration
Population: Participants at 7-10w0d of Gestation were assessed. Participants who were lost to follow-up were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxycodone Arm | 7-10 Weeks Gestation - Maximum Self-reported Pain Score | 9 units on a scale |
| Placebo Arm | 7-10 Weeks Gestation - Maximum Self-reported Pain Score | 8 units on a scale |
Primary
<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).
Time frame: 24 hours after misoprostol administration
Population: Participants at \<7 weeks of Gestation were assessed. Participants who were lost to follow-up were excluded from this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxycodone Arm | <7 Weeks of Gestation - Maximum Self-reported Pain Score | 8 units on a scale |
| Placebo Arm | <7 Weeks of Gestation - Maximum Self-reported Pain Score | 8 units on a scale |
Primary
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).
Time frame: 24 hours after misoprostol administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxycodone Arm | Overall Maximum Self-reported Pain Score | 8 units on a scale |
| Placebo Arm | Overall Maximum Self-reported Pain Score | 8 units on a scale |