TY - JOUR
T1 - Cannabinoids for Pain Control During Medical Abortion
T2 - A Randomized Controlled Trial
AU - Colwill, Alyssa Covelli
AU - Alton, Katie
AU - Bednarek, Paula H.
AU - Bayer, Lisa L.
AU - Jensen, Jeffrey T.
AU - Garg, Bharti
AU - Beardsworth, Kathleen
AU - Edelman, Alison
PY - 2020/6/1
Y1 - 2020/6/1
N2 - OBJECTIVE: To evaluate whether prophylactic dronabinol, a synthetic tetrahydrocannabinol, reduces pain during medical abortion. METHODS: 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 (0=no pain, 10=worst 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. RESULTS: From November 2018 to May 2019, we randomized 70 women (dronabinol=35, placebo=35). 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). CONCLUSION: Dronabinol does not reduce the maximum level of pain experienced by women undergoing medical abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03604341.
AB - OBJECTIVE: To evaluate whether prophylactic dronabinol, a synthetic tetrahydrocannabinol, reduces pain during medical abortion. METHODS: 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 (0=no pain, 10=worst 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. RESULTS: From November 2018 to May 2019, we randomized 70 women (dronabinol=35, placebo=35). 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). CONCLUSION: Dronabinol does not reduce the maximum level of pain experienced by women undergoing medical abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03604341.
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U2 - 10.1097/AOG.0000000000003850
DO - 10.1097/AOG.0000000000003850
M3 - Article
C2 - 32459420
AN - SCOPUS:85085539618
SN - 0029-7844
VL - 135
SP - 1289
EP - 1295
JO - Obstetrics and Gynecology
JF - Obstetrics and Gynecology
IS - 6
ER -