Cannabinoids for Pain Control During Medical Abortion A Randomized Controlled Trial.
To evaluate whether prophylactic dronabinol, a synthetic tetrahydrocannabinol, reduces pain during medical abortion. We conducted a randomized, double-blind, placebo-controlled trial of women undergoing medical abortion with mifepristone and misoprostol up through 70 days of gestation. All participants received 800 mg of ibuprofen and were randomized to either 5 mg of oral dronabinol or a placebo 30 minutes before misoprostol administration. Participants used a text messaging service to report pain on a numeric rating scale from 0 to 10 (0no pain, 10worst pain). The primary outcome was maximum pain experienced during the 24 hours after misoprostol administration. Secondary outcomes were pain scores at 0, 6, and 24 hours after misoprostol administration maximum anxiety and nausea scores use of additional pain medication reported side effects and satisfaction (yes or no). We needed 68 participants (34 per group) to have 80% power to detect a 2-point difference in maximum pain on a numeric rating scale. From November 2018 to May 2019, we randomized 70 women (dronabinol35, placebo35). Participants in the study arms had comparable baseline characteristics. We found no difference between groups in the median maximum pain score reported (dronabinol 7 interquartile range 6-8, placebo 7 interquartile range 5-8, P.82) or median pain scores at any timepoint. Groups were also no different in mean maximum anxiety (dronabinol 3.33 SD 3.06, placebo 3.23 SD 2.53, P.88) or nausea scores (dronabinol 2.21 SD 2.32, placebo 2.72 SD 2.64, P.41). Most women were satisfied with their pain management (76% dronabinol, 82% placebo, P.51). Dronabinol does not reduce the maximum level of pain experienced by women undergoing medical abortion. ClinicalTrials.gov, NCT03604341.