Abortion: Original Research
Opioid Analgesia for Medical Abortion
A Randomized Controlled Trial
Downloaded from https://journals.lww.com/greenjournal by IZYGxX+VPkaMUw9PaaXXnPFD6Vte/TZ69xaK+fCOmSYPi0WPRlTmY8Fc1opSebKv9mtZvNFtkleMF9HBr99r2qblBXmCRwBqPFWc3viiiSC7yKPcHggLV4qJi2bmNRyTWz1+j7t0KIY0mG5iVRexMhGzIh0nuL2aE9UfJa3m4lE= on 12/16/2019
Alyssa Covelli Colwill, MD, MCR, Lisa L. Bayer, MD, MPH, Paula Bednarek, MD, MPH,
Bharti Garg, MBBS, MPH, Jeffery T. Jensen, MD, MPH, and Alison B. Edelman, MD, MPH
OBJECTIVE: To estimate the effect of oral opioids on
patient pain during first-trimester medical abortion.
METHODS: We conducted a randomized, double-blind,
placebo-controlled trial where patients up to 10 0/7
weeks of gestation undergoing a medical abortion with
mifepristone and misoprostol took 10 mg oral oxy-
codone or placebo at onset of painful cramping. Addi-
From the Oregon Health & Science University, Portland, Oregon.
Supported by the Society of Family Planning grant SFPRF17-16. The Society of
Family Planning had no role in the study design, data collection, analysis,
interpretation, writing or decision for publication. The use of REDCap, data
capture system, was supported by National Center for Advancing Translational
Sciences of the National Institutes of Health under award number
UL1TR0002369. The content is solely the responsibility of the authors and does
not necessarily represent the official views of the National Institutes of Health.
The authors thank Planned Parenthood of Columbia Willamette and the Wom-
en’s Health Research Unit of Oregon Health & Science University for providing
recruitment and data collection support. The findings and conclusions in this
article are those of the authors and do not necessarily reflect the views of Planned
Parenthood Federation of America, Inc.
Each author has confirmed compliance with the journal’s requirements for
authorship.
Corresponding author: Alyssa Covelli Colwill, MD, MCR, Oregon Health &
Science University, Portland, OR; email: Colwill@ohsu.edu.
Financial Disclosure
Lisa L. Bayer, MD, MPH is a trainer for Merck & Co for which she receives an
honorarium. Paula Bednarek, MD, MPH, is an author for UpToDate, a trainer
for Nexplanon with Merck & Co and Paragard IUD Speakers Bureau with
Cooper Surgical. Jeffery T. Jensen, MD, MPH, has received payments for consul-
ting from Abbvie, Cooper Surgical, Bayer Healthcare, Merck, Sebela, and the
Population Council. OHSU has received research support from Abbvie, Bayer
Healthcare, Daré, Estetra SPRL, Medicines360, Merck, and Sebela. These com-
panies and organizations may have a commercial or financial interest in the
results of this research and technology. These potential conflicts of interest have
been reviewed and managed by OHSU. Alison Edelman, MD, MPH, is a con-
sultant for World Health Organization, CDC, Gynuity Health Projects,
FHI360, Exeltis, Nexplanon trainer for Merck. Author for UptoDate (royalties
received). Her institution receives research monies from Merck, HRA Pharma,
and NIH on projects where she is principal investigator. These potential conflicts
have been reviewed and managed by OHSU. She is the Chair of the ACOG PB
GYN committee and has received travel and honorarium from ACOG. She is an
expert technical consultant for the CDC and the WHO on reproductive health
issues and has received travel reimbursement. The other authors did not report any
potential conflicts of interest.
© 2019 by the American College of Obstetricians and Gynecologists. Published
by Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0029-7844/19
VOL. 134, NO. 6, DECEMBER 2019
© 2019 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
tionally, all patients received 800-mg ibuprofen tablets,
4-mg ondansetron oral dissolving tablets, and a written
prescription for adjunctive pain medication (six tablets
oxycodone 5 mg). Participants used a text-messaging
service to report pain scores on a numerical rating scale
from 0 to 10 (0 being no pain, 10 being worst pain) for 24
hours at start of misoprostol dosing. The primary out-
come was maximum pain experienced within 24 hours
postmisoprostol. Our secondary outcomes were maxi-
mum pain stratified by gestational age (less than 7 weeks
of gestation, 7–10 weeks of gestation), duration of max-
imum pain, use of adjunctive medication, presence of
nausea or vomiting, and satisfaction. We needed at least
76 participants per group to differentiate a clinically
important pain difference of 2 points on the numerical
rating scale.
RESULTS: From May 2017 to May 2018, we randomized
172 participants (placebo group with 86, oxycodone
group with 86). The study groups had comparable
baseline characteristics. We found no difference
between groups in median maximum pain scores (pla-
cebo 8 [range 1–10], oxycodone 8 [range 2–10], P5.92)
and the median duration of maximum pain (placebo 0.75
hours range 0.01–15 vs oxycodone 1 hour range 0.02–10,
P5.39). Groups were also similar in the proportion ob-
taining (placebo 62%, oxycodone 49%, P5.09) and using
(placebo 48%, oxycodone 40%, P5.28) adjunctive medi-
cation, experiencing nausea or vomiting (placebo 59%,
oxycodone 65%, P5.43) and reported satisfaction with
pain medications (placebo 62%, oxycodone 65%, P5.63).
CONCLUSION: Oxycodone does not reduce the maxi-
mum level of pain experienced by women undergoing
medical abortion up to 10 0/7 weeks of gestation or
improve satisfaction.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
NCT03139240.
(Obstet Gynecol 2019;134:1163–70)
DOI: 10.1097/AOG.0000000000003576
M
ore than a quarter of a million medical abor-
tions are performed annually in the United
OBSTETRICS & GYNECOLOGY 1163
States.1 Medical abortion with mifepristone and miso-
prostol is the recommended regimen by the American
College of Obstetricians and Gynecologists and the
World Health Organization.2–4 Medical abortion has
been extensively studied and is safe.5 However,
abortion-related pain has not been systematically
studied in clinical trials, limiting our ability to recom-
mend appropriate analgesia.6 Medical abortion has
been described as painful in 36–86% of patients, with
up to one-third reporting more pain than antici-
pated.4,7–9
Nonsteroidal antiinflammatory drugs (NSAIDs)
are the cornerstone of analgesia regimens for
abortion-related pain. Yet, NSAIDs do not provide
sufficient pain relief for many women undergoing
medical abortion.10 Clinicians often prescribe oral
opioids as an adjunct to NSAIDs to aid in pain control
for medical abortion but no consensus exists on the
use of opioids in this setting.11,12 The one randomized
controlled trial that exists found no difference in pain
score among women who received either ibuprofen or
acetaminophen with codeine during methotrexate and
misoprostol medical abortion, but the conclusions are
limited by underdosing of a weak opioid.13
Immediate release oxycodone is known to be
effective for severe pain outside of abortion care.14,15
We hypothesized that a more potent opioid could
decrease the overall pain experienced during medical
abortion. Our primary objective of this study was to
estimate whether ibuprofen plus a strong opioid (oxy-
codone) given at a dose recommended for severe pain
decreases pain scores in women undergoing medical
abortion as compared with ibuprofen alone.
METHODS
We conducted a randomized, double-blind, placebo-
controlled trial based at Planned Parenthood Colum-
bia Willamette in Oregon from May 2017 to May
2018. The Institutional Review Board at Oregon
Health & Science University approved the study pro-
tocol. Women were invited to participate in the study
after choosing and consenting to a medical abortion.
Our main eligibility criteria were women aged 18
years or older, with gestations up to 10 0/7 weeks of
gestation with no diagnosis of an early pregnancy fail-
ure, able to receive text messages, literate in English,
able to avoid driving or alcohol use while taking study
medications, no past use of methadone or heroin, no
marijuana use greater than four times per week, no
opioid use in the past 30 days, and no use of other
pain medications. All participants completed written
informed consent before any study procedures.
1164 Colwill et al Opioid Analgesia for Medical Abortion
© 2019 by the American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
We collected baseline information including
demographic, medical, and pregnancy history; body
mass index; estimated gestational age by ultrasound
examination; and anticipated maximum pain using an
11-point numerical rating scale (0–10). Oregon Health
& Science University research pharmacy staff gener-
ated, assigned, and maintained the computer-
generated 1:1 randomization scheme with random
blocks ranging from 5–16. We did not collect baseline
demographics on participants who were not random-
ized. The study drugs, 10 mg oxycodone or an iden-
tical placebo, were labelled in identical sequentially
numbered bottles. Study staff, participants, and health
care providers were blinded to treatment assignments;
the randomization sequence was only unblinded after
completion of all data collection and entry.
Our primary outcome was to determine whether
women undergoing medical abortion who receive
oxycodone 10 mg and ibuprofen 800 mg will report
maximum pain scores at least 2 points lower on
a numerical rating scale as compared with women
using ibuprofen 800 mg and placebo within 24 hours
postmisoprostol. Our secondary outcomes included
maximum reported pain score stratified by gestational
age (less than 7 weeks of gestation, 7–10 weeks of
gestation), duration of maximum pain, number of ibu-
profen tablets used, and use of adjunctive oxycodone.
All participants received four 200-microgram
misoprostol buccal tablets for use 24–48 hours after
mifepristone, six 4-mg ondansetron oral dissolving
tablets to take as needed for nausea, and nine 800-
mg ibuprofen tablets to start up to 1 hour before mi-
soprostol administration and every 8 hours as needed
for cramping. Participants were given one study drug
tablet (10 mg oxycodone or identical placebo) to take
at the onset of uterine cramping. In addition, we pro-
vided participants a paper prescription for six oxyco-
done 5-mg oral tablets (1 tablet orally every 4 hours as
needed for pain) to fill and use only if needed
(“adjunctive” medication).
Study staff launched the text-message platform
when participants notified them of misoprostol inges-
tion (0 hours). At 6 and 24 hours, participants
responded to an automated survey using text message
(TextIt), which included questions on maximum pain
(11-point numerical rating scale), duration of maxi-
mum pain, time of study drug administration, number
of ibuprofen tablets used, whether the oxycodone
adjunctive prescription was filled (yes or no) and used
(yes or no; if yes, number of tablets taken), nausea or
vomiting (yes or no), satisfaction with pain medica-
tions (yes or no), adequacy of blinding (do you believe
the study drug was oxycodone or placebo?), whether
OBSTETRICS & GYNECOLOGY
other medical and nonmedical therapies were used for
pain (free text), and belief of passing the pregnancy
(yes or no).
Participants returned for a standard follow up visit
within 21 days for confirmation of medical abortion
success.16 We reviewed medical records to verify
completion of medical abortion as well as to check
for unanticipated phone calls or visits. If a participant
did not return to this scheduled visit, we sent a text
message to check whether the participant was “feeling
back to normal” and had seen another health care
provider. We considered a participant lost to follow-
up if we received no notification of misoprostol inges-
tion, no response to text or phone contacts during
data collection, or they did not return to their
follow-up visit (or no response to text or phone
contact).
Previous studies suggest that the 11-point
numeric pain scale is as sensitive to changes in
clinical pain as the visual analog scale and a change
of 2 points or more is needed to determine
a difference in pain intensity.17,18 We based our
sample on the assumptions of nonnormally distrib-
uted data, and used a Wilcoxon rank-sum test data
simulation using specified parameters (delta52,
sigma52.6, alpha50.05) for a moderate effect. A
sample size of 34 participants per group provided
80% probability of detecting the 2-point difference
in the simulated data. To allow equal power for
stratification by the two gestational age groups, we
doubled the sample and to allow for up to 10%
drop-out, we planned to enroll 152 participants (less
than 7 weeks of gestation: 38 placebo, 38 oxyco-
done; 7–10 weeks of gestation: 38 placebo, 38 oxy-
codone). Before completion of the study, without
breaking the randomization schema or further eval-
uating outcomes, we found that 30.8% of enrolled
participants had not taken the study drug. There-
fore, we increased the total enrollment by 25% in
the less than 7 weeks of gestation group to a total of
172 participants to have sufficient power to deter-
mine our primary outcome (less than 7 weeks of
gestation: 48 placebo, 48 oxycodone; 7–10 weeks
of gestation: 38 placebo, 38 oxycodone).
We used the REDCap electronic data capture
tool at Oregon Health & Science University for data
management. We exported data directly from RED-
Cap into Stata 15.1 for statistical analysis. We used
independent two-sample t-tests to compare continu-
ous variables, x2 tests to compare categorical variables
and Wilcoxon rank-sum tests to compare medians.
Odds ratios (ORs) were computed using simple logis-
tic regression. We analyzed our primary cohort using
VOL. 134, NO. 6, DECEMBER 2019
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an intent-to-treat approach. Additionally, we per-
formed a per-protocol analysis.
RESULTS
We screened a total of 512 women and randomized
172 (86 per treatment group; Fig. 1). Regarding ges-
tational age stratification, we recruited 96 women with
gestations of less than 7 weeks and 76 women with
gestations between 7 and 10 weeks. Text-message sur-
veys were completed by 170 of 172 (98.8%) of partic-
ipants. Treatment groups did not differ in
demographic characteristics (Table 1) but when strat-
ified by gestational age (Appendix 1, available online
at http://links.lww.com/AOG/B626), more Hispanic
women were allocated to oxycodone in the later ges-
tational age groups (P5.01).
Overall, women reported that their maximum
reported pain level was a median of eight. We found
no difference in the maximum reported pain level
between the treatment (P5.92, Table 2) or the strati-
fied gestational age treatment (7 weeks of gestation or
less P5.75; greater than 7 weeks of gestation P5.62,
Table 3) groups. We also performed noninferiority
testing and the maximum pain scores did not differ
between groups by more than 1 point on the numer-
ical rating scale (P5.001). Oxycodone treatment did
not reduce the proportion of women with reported
moderate-severe pain (numerical rating scale greater
than 7) or the maximum median duration of pain,
which was about 1 hour in length (P5.39, Tables 2
and 3). The onset of maximum mean pain occurred
approximately 2 hours postmisoprostol in both the
treatment (Table 2) and the stratified gestational age
groups (Table 3). Baseline anticipated pain correlated
with the maximum pain that participants experienced
(r50.43, P,.01).
Participants used a similar median number of
ibuprofen tablets [oxycodone 2 (range 0–9), placebo 2
(range 0–7), P5.59]. At least half of all participants
filled their adjunctive medication prescription but
there was no difference between groups (oxycodone
49%, placebo 62%, P5.09; less than 7 weeks of gesta-
tion: oxycodone 50%, placebo 66%, P5.11; 7–10
weeks of gestation: oxycodone 49%, placebo 58%,
P5.42). Less than half of the participants in either
group used the adjunctive medication (oxycodone
40%, placebo 48%, P5.28) and the median number
of adjunctive oxycodone tablets used was two (total 10
mg) (Table 2, P5.59). In total, we prescribed 1,032
tablets of oxycodone for adjunctive medication (six
tablets per participant). Our research population only
used 15% of what we prescribed—leaving 85% of pre-
scribed tablets unused. Only four women (2% of the
Colwill et al Opioid Analgesia for Medical Abortion 1165
Fig. 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram.
Colwill. Opioid Analgesia for Medical Abortion. Obstet Gynecol 2019.

cohort) used all six tablets of the adjunctive oxyco-
done medication. No one reported using more than
the six tablets prescribed.
We performed a per-protocol analysis to com-
pare our main outcomes between participants that
adhered to the study protocol by taking the study
drug as prescribed (Table 4). We found no differ-
ences in baseline characteristics, maximum re-
ported pain score, duration of pain, number of
ibuprofen tablets used, proportion of participants
who filled and used oxycodone, or satisfaction
(Appendices 2 and 3, available online at http://
links.lww.com/AOG/B626). A total of 49 partici-
pants (placebo group n521; oxycodone group
n528) did not follow the protocol by: not taking
study drug but taking the baseline ibuprofen (pla-
cebo group n516; oxycodone group n524); taking
ibuprofen and adjunctive drug without study drug

1166 Colwill et al Opioid Analgesia for Medical Abortion OBSTETRICS & GYNECOLOGY

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and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
Table 1. Characteristics

Characteristic Oxycodone (n586) Placebo (n586)

Age (y) 2766 2767

Race–ethnicity
White, non-Hispanic 52 (60) 41 (48)
Other 34 (40) 45 (52)
Parity
Nulliparous 33 (39) 35 (41)
Parous 53 (61) 51 (59)
Obstetric history
Prior vaginal deliveries 36 (42) 41 (48)
Prior cesarean deliveries 6 (7) 6 (7)
Prior medical abortions 22 (26) 17 (20)
Prior surgical abortions 17 (20) 15 (17)
BMI (kg/m2) 2766 2768
Education
High school or less 20 (23) 30 (35)
College (any) 66 (77) 56 (65)
Gestational age (d) 4768 4869
BMI, body mass index.
Data are mean6SD or n (%).

(placebo group n52; oxycodone group n52); tak-
ing study drug and not taking ibuprofen or adjunc-
tive medication (placebo group n51; oxycodone
group n51); or who took no medications at all (pla-
cebo group n52; oxycodone group n51) (Appen-
dix 4, available online at http://links.lww.com/
AOG/B626). We performed additional analyses to
compare our main outcomes between participants
that did and did not take study drugs. We found
no differences in baseline characteristics, however
nonprotocol followers were more likely to report
lower maximum pain (P,.01), a decreased duration
of maximum pain (P,.01), and use less ibuprofen
and adjunctive pain medication (P,.01) (Appendi-
ces 5 and 6, available online at http://links.lww.
com/AOG/B626).
Women’s satisfaction with the prescribed pain
medication did not differ between treatment groups
(OR 1.16; 95% CI 0.62–2.18). The incidence of nau-
sea or vomiting was similar between groups (OR 1.28;
95% CI 0.69–2.38). Blinding to allocation group was
adequate (placebo 70%, oxycodone 47% P5.09).
The majority of women completed their follow up
(85%, 150/172; in-person visit n5135 participants,
text message: n515) and this did not differ by treat-
ment group (P5.85). Thirteen percent (22/170) of par-
ticipants made an extra phone call to Planned
Parenthood Columbia Willamette or to the study
phone but only six (4%) total participants called with
complaints of pain (four placebo, two oxycodone).
Ten women had unscheduled visits with Planned Par-
enthood Columbia Willamette or another health care
provider (oxycodone four, placebo six, P5.81); one
for pain, one for bleeding, and eight for nonurgent
issues.
Two women had incomplete abortions or an
ongoing pregnancy requiring surgical aspiration (oxy-
codone one, placebo one) as confirmed at their follow-
up appointment, which is consistent with the typical
completion rate for medical abortion of 95–99%.2
One additional woman required an extra dose of mi-
soprostol to complete, and one participant completed
with expectant management (oxycodone two, placebo
zero). All of these participants reported by text survey
that they believed they had passed the pregnancy. No
participant reported a serious adverse event due to the
study drugs. One participant in the oxycodone group
presented to the emergency department with dizziness
and was diagnosed with an inner ear infection. One
participant in the placebo group presented with heavy
bleeding, which was treated with expectant
management.
DISCUSSION
We found that oxycodone does not reduce the
amount or duration of maximum pain experienced
or the duration of overall pain in women undergoing
medical abortion up to 10 0/7 weeks of gestation. Our
findings did not differ by gestational age. Overall, we
found that the use of opioids provided no overall
benefit for pain control for women undergoing
medical abortion. Our study also helps to further

VOL. 134, NO. 6, DECEMBER 2019 Colwill et al Opioid Analgesia for Medical Abortion 1167

© 2019 by the American College of Obstetricians

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Table 2. Primary and Secondary Outcomes of Entire Cohort (Intention-to-Treat Analysis)

Result Oxycodone (n585) Placebo (n585) P

Primary outcome
Maximum pain score* 8 (2–10) 8 (1–10) .92
Secondary outcomes
Duration of maximum pain (h) 1 (0.02–10) 0.75 (0.01–15) .39
Reported maximum pain score greater than 7 49 (58) 51 (60) .75
Onset of worst pain from misoprostol administration (h) 2.361.4 2.661.6 .17
No. of ibuprofen tablets used 2 (0–9) 2 (0–7) .59
Filled adjunctive oxycodone prescription 42 (49) 53 (62) .09
Took adjunctive oxycodone medication 34 (40) 41 (48) .28
No. of adjunctive oxycodone tablets used 2 (1–6) 2 (1–6) .59
Satisfied with pain medications 56 (65) 53 (62) .63
Presence of nausea or vomiting 55 (65) 50 (59) .43
Took study medication 58 (68) 65 (77) .23
Belief of completed abortion (24 h postmisoprostol use) 65 (77) 63 (75) .72
Data are median (range), n (%), or mean6SD unless otherwise specified.
* 11-point numerical rating scale.

characterize the pain experienced by women under-
going medical abortion as it has not been well-
described. Women reported a relatively high peak
pain level of 8 out of 10 on a numerical rating scale,
which occurred 2.5 to 4 hours after misoprostol use
and lasted for about 1 hour.
Interestingly, we had a relatively high proportion
of women who did not adhere to the study protocol.
The majority of these women used ibuprofen alone
and had lower reported pain scores and shorter
duration of pain than protocol followers, implying
that their pain was not severe enough to need
additional opioids and that ibuprofen was sufficient.
Because we did not initially account for so many
women deviating from protocol, we increased our
sample size in the lower gestational age cohort to be
powered to analyze our primary outcome. However,
analyzing our outcomes using a per-protocol analysis
also failed to show a difference in maximum pain
scores, strengthening our conclusions that the use of
opioids does not reduce maximum pain induced by
medical abortion.
Women were instructed to take oxycodone at the
onset of uterine cramping in an attempt to provide

Table 3. Stratification by Gestational Age in Intent-to-Treat Cohort

Less Than 7 Wk of Gestation 7–10 Wk of Gestation

Oxycodone Placebo Oxycodone Placebo
Result (n548) (n547) P (n537) (n538) P

Maximum pain score* 8 (2–10) 8 (1–10) .75 9 (2–10) 8 (4–10) .62

Duration of maximum pain (h) 0.79 (0.02–10) 0.75 (0.02–12) .79 2 (0.08–10) 0.75 (.01–15) .28
Reported maximum pain score greater than 7 26 (54) 28 (60) .59 23 (62) 23 (61) .88
Onset of worst pain from misoprostol 2.361.4 2.861.6 .10 2.261.5 2.361.5 .82
administration (h)
No. of ibuprofen tablets used 2.5 (1–9) 2 (0–5) .94 2 (0–5) 2 (0–7) .34
Filled adjunctive oxycodone prescription 24 (50) 31 (66) .11 18 (49) 22 (58) .42
Took adjunctive oxycodone medication 19 (40) 22 (47) .48 15 (41) 19 (50) .41
No. of adjunctive oxycodone tablets used 2 (1–6) 2 (1–4) .83 2 (1–6) 2 (1–6) .58
Satisfied with pain medications 34 (71) 29 (62) .35 22 (59) 24 (63) .74
Presence of nausea or vomiting 31 (65) 25 (53) .26 24 (65) 25 (66) .93
Took study medication 33 (69) 35 (75) .53 25 (67) 30 (79) .26
Belief of completed abortion (24 h 34 (72) 32 (68) .65 31 (84) 31 (84) 1.00
postmisoprostol use)
Data are median (range), n (%), or mean6SD unless otherwise specified.
* 11-point numerical rating scale.

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© 2019 by the American College of Obstetricians

and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
Table 4. Results of Protocol Followers (Per-Protocol Analysis)

Oxycodone (n557) Placebo (n564) P

Maximum pain score* 9 (2–10) 8 (4–10) .60

Duration of maximum pain (h) 2 (0.08–10) 1 (0.02–15) .21
Onset of worst pain from misoprostol administration (h) 2.261.4 2.561.6 .27
Reported maximum score greater than 7 40 (70) 45 (70) .99
Ibuprofen tablets used 2 (1–9) 2 (1–7) .77
Filled adjunctive medication 38 (67) 47 (73) .42
Used adjunctive medication 32 (56) 39 (61) .59
Adjunctive oxycodone used 1 (0–6) 1 (0–6) .92
Satisfaction with pain medications 39 (68) 37 (58) .23
Presence of nausea or vomiting 39 (68) 43 (67) .88
Adequacy of blinding (percentage who guessed allocation group correctly) 27 (47) 45 (70) .09
Data are median (range), mean6SD, or n (%) unless otherwise specified.
* 11-point numerical rating scale.

pain relief when needed most. We feel it is unlikely
that the timing of administration was too late to
provide participants’ coverage of their peak pain,
because oxycodone provides analgesic relief in as
soon as 15 minutes. Even if women missed the peak
coverage with administration, we would anticipate
a shorter duration of pain, but we did not find this.
We did find that a significant subset of women still
experience severe pain, despite use of ibuprofen and
oxycodone, indicating an area of focus for future
research.
The major strength of this study is its design as
a placebo-controlled, double-blind, randomized con-
trolled trial, which reduced confounding. Our study is
the only one to date that examines the effect of opioid
use for medical abortion using the current recom-
mended regimen with mifepristone and misoprostol.
We used an oxycodone dosage of 10 mg, which is
appropriate to treat severe pain. In addition, oxy-
codone was only available at this clinic to eligible
women through study participation to increase inter-
nal validity. Our data collection rate was near 100%,
indicating text messaging is a reliable form of data
collection in this population. Text-message use also
increased follow-up data for women who were unable
to return to their scheduled clinic visit.
Limitations include that the adjunctive medica-
tion was prescribed and not dispensed, potentially
a limiting factor for women who may not have had
access to it owing to financial or logistical issues, thus
potentially lowering its use if it were otherwise
dispensed. This clinic site did not prescribe routine
opioids. Providing a prescription mimics most clinical
scenarios, so the usage rate in this study likely
simulates real-world usage. Women who enrolled
had to be accepting of the possibility of using an
opioid and be opioid naive, which may skew the
population towards women who are fearful of pain
and more likely to use opioids. Our exclusion criteria
limit the generalizability of our results for women who
may experience pain differently, such as those who
have or are using illicit drugs or chronic opioids or
women with chronic pain disorders. A participant’s
anticipated pain did strongly correlate with experi-
enced pain. Therefore, it would be reasonable to use
this information to determine whether to offer addi-
tional therapies to aid in pain control on an individual
patient basis. Although we did not study pain man-
agement for medical management of early pregnancy
loss, we believe, given the similarities in the pain
experience, that it is reasonable to extrapolate our
study findings to this patient population as well.
As health care providers, we have been the largest
contributor to the opioid epidemic, but changing pre-
scribing patterns can have a significant effect on
exposure and availability of opioids to the public. Even
with prescribing few tablets, 85% (874 tablets) of the
prescribed oxycodone tablets for adjunctive medication
went unused. Therefore, all opioid prescribing patterns
should be evaluated and individualized to prevent
overprescribing. We can conclude that routinely pre-
scribing opioids for medical abortion up to 10 0/7 weeks
of gestation is unnecessary, but, if opioids are requested,
we would recommend providing four tablets or fewer.
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Authors’ Data Sharing Statement
Will individual participant data be available (including
data dictionaries)? Yes.
What data in particular will be shared? All de-identified
individual participant data collected during the trial.
What other documents will be available? Study protocol.
When will data be available (start and end dates)? Imme-
diately following publication and ending 3 years after
article publication.
By what access criteria will data be shared (including
with whom, for what types of analyses, and by what
mechanism)? Researchers who provide a methodolog-
ically sound proposal and rationale for use of the data
set, their proposed analyses and results through aca-
demically established means. Oregon Health & Sci-
ence University maintains a high community standard
for the free release of data and materials. Transfer of
resources is subject to the acceptance of a Materials
Transfer Agreement as required by policy at Oregon
Health & Science University. Oregon Health & Sci-
ence University understands and agrees to comply
with the NIH policy on Sharing Research Data and
on Sharing Model Organisms.
PEER REVIEW HISTORY
Received June 18, 2019. Accepted September 12, 2019. Peer re-
views and author correspondence are available at http://links.lww.
com/AOG/B627.
OBSTETRICS & GYNECOLOGY