Nitrous Oxide Versus Intravenous Sedation for Anesthesia



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:7/27/2016
Start Date:July 2016
End Date:June 2017
Contact:Family Planning Research, UNM
Email:HSC-FamilyPlanningResearch@salud.unm.edu

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Trial Summary
Trial Overview
Inclusion Criteria
This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of
inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl
and midazolam, for pain management in adult women having a pregnancy termination procedure
between 12 and 16 weeks gestational age.

This study will evaluate whether nitrous oxide is a feasible and acceptable alternative to
IV sedation for pain management during early second trimester D&E. Primary endpoints will
include maximum procedural pain using the visual analog scale (VAS) as well as satisfaction
with anesthesia using the Iowa Satisfaction with Anesthesia Scale.

Inclusion Criteria:

- 18 years old or older

- pregnancy termination at gestational age of 12-16 weeks

- able to read and understand either English or Spanish

- able to obtain reliable post-procedure transportation

Exclusion Criteria:

- contraindications to outpatient pregnancy termination

- contraindications to nitrous oxide use (such as pernicious anemia, current treatment
with bleomycin chemotherapy, active upper respiratory illness, or COPD)

- intrauterine fetal demise

- chronic narcotic use

- known adverse reaction to nitrous oxide, Fentanyl, or Versed
We found this trial at
2
sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
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Albuquerque, NM
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University of Colorado
Denver, Colorado 80210
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Denver, CO
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