The experience of pain in real-time during medication abortion.

OBJECTIVE: We aimed to characterize the current pain experience of patients completing an evidence-based mifepristone-misoprostol medication abortion regimen using real-time pain scores. STUDY DESIGN: We collected real-time data on pain experienced by 54 women undergoing medication abortion using an evidence-based regimen of 200 mg mifepristone and 800 mcg buccal misoprostol. These women were enrolled in the placebo arm of a study on the effect of pregabalin for pain during medication abortion. All participants were dispensed ibuprofen and oxycodone/acetaminophen for analgesia. We assessed maximum pain experienced by participants on an 11-point numerical rating scale (NRS), duration of pain, and analgesic usage. Data was collected through electronic surveys sent via text message link at 6 specified points over 72 hours. RESULTS: Of the 54 women randomized to the placebo group, 2 were lost to follow-up. Participants experienced a mean maximum pain score of 5.5 ± 2.2. The mean time to maximum pain was 3.7 ± 2.4 hours after misoprostol. By hour 12 after misoprostol, 60.8% of participants reported no pain, which increased to 76.9% at 24 hours and 82.0% at 72 hours. Participants reported median ibuprofen usage of 2 800 mg tablets and median oxycodone/acetaminophen usage of one-half of a 5/325mg tablet. Approximately 12.0% of participants reported taking zero ibuprofen tablets, and 50.0% reported no opioid usage during the study period. CONCLUSIONS: Our real-time data collection demonstrated lower mean maximum experienced pain scores and shorter duration of pain than previously reported for medication abortion. Analgesic use was lower than previously described. IMPLICATIONS: This updated characterization of pain experienced during an evidence-based medication abortion regimen may allow for better pain-related counseling, tailoring of opioid prescription practices, and improvement in patient satisfaction.

Text message link to online survey: A new highly effective method of longitudinal data collection.

OBJECTIVES: To evaluate response rate to a text message link for an online survey as a method of data collection over the course of a medication abortion. STUDY DESIGN: This is a secondary analysis of a randomized, double-blind, placebo-controlled trial of 110 women initiating a medication abortion up to 70 days gestation. We sent a text message containing a link to an online survey collecting pain scores, analgesic use, and adverse effects at six time points over 72 h from time of misoprostol administration (0-, 2-, 6-, 12-, 24-, and 72-hours). Our primary outcome was the proportion of all text messages sent for which an online survey response was received. Secondary outcomes included the proportion of complete responses (all six surveys), responses received more than two hours after text prompt (defined as late), and differences in response rate by time of day. RESULTS: From June 2015 to October 2016, we screened 241 women, and 110 were randomized. We excluded three (1.2%) due to lack of a cellular phone with text capability, and three (2.7%) were lost to follow-up after enrollment. We received a response to 95.9% (633/660) of the delivered surveys, and 93.6% (103/110) of participants completed all six surveys. Over three-quarters of all responses were received within two hours of the requested time. Surveys sent before 08:00 were more likely to be returned late. CONCLUSIONS: In this population of women seeking medication abortion, text message link to online survey response appears to be an effective mode of data collection. IMPLICATIONS: Text message prompts for an online survey may optimize longitudinal real-time data collection response rates of sensitive data.

Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether prophylactic pregabalin reduces pain experienced with medication abortion. METHODS: 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. RESULTS: 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). CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02782169.