Objective: To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion.
Methods: Between 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 (power580%; significance level5.025) 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.
Results: Demographics were similar between groups (placebo562, midazolam562). 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, P5.02). There was
no difference in pain (P5.28) or anxiety (P5.14) 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, P5.005) and dizziness (30/61 compared with 18/61, P5.03). Controlling for baseline differences,
patients who received midazolam reported more postoperative sleepiness (P,.001) and less postoperative nausea (P5.004). There was no difference in overall satisfaction
(P5.88).
Conclusion: Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions.