title: An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial.
abstract: 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 (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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881.
  
  
  METHODS
  I.
authors.affiliation: 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.
authors.forename: Lisa L
authors.initials: LL
authors.lastname: Bayer
authors.forename: Alison B
authors.initials: AB
authors.lastname: Edelman
authors.forename: Rongwei
authors.initials: R
authors.lastname: Fu
authors.forename: William E
authors.initials: WE
authors.lastname: Lambert
authors.forename: Mark D
authors.initials: MD
authors.lastname: Nichols
authors.forename: Paula H
authors.initials: PH
authors.lastname: Bednarek
authors.forename: Kelsey
authors.initials: K
authors.lastname: Miller
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Jensen
mesh_terms: D000028:Abortion, Induced / Q000009:adverse effects* / Q000379:methods / Q000523:psychology; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016014:Linear Models; D008874:Midazolam / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000517:prevention & control*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D014151:Anti-Anxiety Agents; D008874:Midazolam