An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion

A Randomized Controlled Trial

Lisa L. Bayer, Alison Edelman, Rongwei (Rochelle) Fu, William Lambert, Mark D. Nichols, Paula Bednarek, Kelsey Miller, Jeffrey Jensen

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 (power80%; 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 (placebo62, midazolam62). 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

Original languageEnglish (US)
Pages (from-to)37-46
Number of pages10
JournalObstetrics and Gynecology
Volume126
Issue number1
DOIs
StatePublished - Jul 23 2015

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Midazolam
First Pregnancy Trimester
Anxiety
Randomized Controlled Trials
Pain
Placebos
Obstetrical Anesthesia
Pain Perception
Ibuprofen
Visual Analog Scale
Demography
Pregnancy

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Medicine(all)

Cite this

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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 (power80{\%}; 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 (placebo62, midazolam62). 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",
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AU - Bayer, Lisa L.

AU - Edelman, Alison

AU - Fu, Rongwei (Rochelle)

AU - Lambert, William

AU - Nichols, Mark D.

AU - Bednarek, Paula

AU - Miller, Kelsey

AU - Jensen, Jeffrey

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AB - 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 (power80%; 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 (placebo62, midazolam62). 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

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