• Lisa L Bayer, Alison B Edelman, Rongwei Fu, William E Lambert, Mark D Nichols, Paula H Bednarek, Kelsey Miller, and Jeffrey T Jensen.
• Department of Reproductive Medicine, University of California, San Diego, San Diego, California; and the Departments of Public Health and Preventive Medicine, School of Medicine, and Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon.
• Obstet Gynecol. 2015 Jul 1;126(1):37-46.

ObjectiveTo estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion.MethodsBetween May and December 2013, we conducted a randomized, double-blind, placebo-controlled trial. Patients between 6 0/7 and 10 6/7 weeks of gestation received 10 mg oral midazolam or placebo 30-60 minutes before surgical abortion. All patients received ibuprofen and a paracervical block. We powered the study (power=80%; significance level=.025) to detect a 15-mm difference in our two a priori primary outcomes of pain and anxiety with uterine aspiration on a 100-mm visual analog scale. Secondary outcomes were pain and anxiety at additional time points, memory, satisfaction, side effects, and adverse events.ResultsDemographics were similar between groups (placebo=62, midazolam=62). Compared with those randomized to placebo, patients who received midazolam had significantly less anxiety preoperatively (room entry: 51.4 mm compared with 34.5 mm, P<.001; positioning: 56.6 mm compared with 45.4 mm, P=.02). There was no difference in pain (P=.28) or anxiety (P=.14) during uterine aspiration or at other procedural time points. A significantly greater number of patients in the midazolam group reported partial amnesia (31/61 compared with 16/61, P=.005) and dizziness (30/61 compared with 18/61, P=.03). Controlling for baseline differences, patients who received midazolam reported more postoperative sleepiness (P<.001) and less postoperative nausea (P=.004). There was no difference in overall satisfaction (P=.88).ConclusionAlthough oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions.Clinical Trial RegistrationClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881.Level Of EvidenceI.

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