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).

CONCLUSION:

Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881.

LEVEL OF EVIDENCE:

I.

• Authors: Lisa L Bayer, Alison B Edelman, Rongwei Fu, William E Lambert, Mark D Nichols, Paula H Bednarek, Kelsey Miller, Jeffrey T Jensen
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 126 Issue 1 Pg. 37-46 (Jul 2015) ISSN: 1873-233X [Electronic] United States
• PMID: 26241254 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Anti-Anxiety Agents
• Midazolam

Topics

• Abortion, Induced (adverse effects, methods, psychology)
• Administration, Oral
• Adolescent
• Adult
• Analgesics (therapeutic use)
• Anti-Anxiety Agents (therapeutic use)
• Anxiety (etiology, prevention & control)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Linear Models
• Midazolam (therapeutic use)
• Pain Measurement
• Pain, Postoperative (diagnosis, prevention & control)
• Pregnancy
• Pregnancy Trimester, First
• Treatment Outcome
• Young Adult