An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial

• Published in: Obstetrics and gynecology (New York. 1953) Vol. 126; no. 1; pp. 37 - 46
• Main Authors: Bayer, Lisa L, Edelman, Alison B, Fu, Rongwei, Lambert, William E, Nichols, Mark D, Bednarek, Paula H, Miller, Kelsey, Jensen, Jeffrey T
• Format: Journal Article
• Language: English
• Published: United States 01.07.2015
• Subjects: Abortion, Induced - adverse effects; Abortion, Induced - methods; Abortion, Induced - psychology; Administration, Oral; Adolescent; Adult; Analgesics - therapeutic use; Anti-Anxiety Agents - therapeutic use; Anxiety - etiology; Anxiety - prevention & control; Double-Blind Method; Drug Administration Schedule; Female; Humans; Linear Models; Midazolam - therapeutic use; Pain Measurement; Pain, Postoperative - diagnosis; Pain, Postoperative - prevention & control; Pregnancy; Pregnancy Trimester, First; Treatment Outcome; Young Adult
• ISSN: 0029-7844; 1873-233X
• DOI: 10.1097/AOG.0000000000000913

To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion. 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 (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. Demographics 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). Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881. I.