To evaluate whether prophylactic pregabalin reduces pain experienced with medication abortion.
We conducted a randomized, double-blind, placebo-controlled trial of women initiating medication abortion with mifepristone and buccal misoprostol up to 70 days of gestation. Participants were randomized to 300 mg oral pregabalin or a placebo immediately before misoprostol. The primary outcome was maximum pain on an 11-point numerical rating scale, reported using real-time electronic surveys over 72 hours. Secondary outcomes included pain at each time point, ibuprofen and narcotic use, side effects, and satisfaction. We estimated that 110 women would be required to have 80% power to detect a difference in pain of 1.3 points.
Between June 2015 and October 2016, 241 women were screened and 110 were randomized (56 pregabalin, 54 placebo). Three were lost to follow-up. The primary outcome of mean maximum pain in the pregabalin group was 5.0±2.6 vs 5.5±2.2 in the placebo group (P=.32). Excluding medication taken before the study capsule, ibuprofen was used by 64% (35/55) of the pregabalin group vs 87% (45/52) placebo (P<.01). Narcotics were used by 29% (16/55) of the pregabalin group vs 50% (26/52) placebo (P<.03). More dizziness (P<.001), sleepiness (P<.04), and blurred vision (P<.05) occurred in the pregabalin group. Satisfaction scores for the analgesic regimen were higher in the pregabalin group (very satisfied: 47% vs 22%; P=.006).
Compared with placebo, 300 mg pregabalin coadministered with misoprostol during medication abortion did not significantly decrease maximum pain scores. Women who received pregabalin were less likely to require any ibuprofen or narcotic and were more likely to report higher satisfaction with analgesia, despite an increase in dizziness, sleepiness, and blurred vision.
Prophylactic pregabalin during medication abortion is not associated with lower pain scores but is associated with a decreased need for analgesics and higher satisfaction scores.
Department of Obstetrics, Gynecology & Women's Health, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, Hawaii.
Corresponding author: EmmaKate B. Friedlander, MD, PhD, 642 Ulukahiki Street, Suite 305, Kailua HI 96734; email: email@example.com.
Supported by the Society of Family Planning Research Fund, Grant Award Number SFPRF15-12.
Presented at the North American Forum on Family Planning, October 14–16, 2017, Atlanta, Georgia.
Financial Disclosure Dr. Soon receives research support from Contramed Pharmaceuticals, Merck Sharpe and Dohme, Mithra Pharmaceuticals, and Gynuity Health Projects. Dr. Tschann receives research support from Contramed Pharmaceuticals, Merck Sharpe and Dohme, Mithra Pharmaceuticals, Gynuity Health Projects, and the National Institutes of Health. Dr. Kaneshiro receives research support from Contramed Pharmaceuticals, Merck Sharpe and Dohme, Mithra Pharmaceuticals, Gynuity Health Projects, and the National Institutes of Health. She is also a consultant for UpToDate. All of these sources of outside research support did not play any role in this project's study design, data collection, analysis, interpretation, writing of the report, or decision to submit the report for publication. The other authors did not report any potential conflicts of interest.
Each author has indicated that he or she has met the journal's requirements for authorship.
Received February 24, 2018
Received in revised form April 25, 2018
Accepted May 10, 2018