Skip to main content
OpenTrials
Completed

NCT Number: NCT02755090

Nitrous Oxide Versus Intravenous Sedation for Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Termination in Second Trimester Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous Oxide

Drug

Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.

IV Saline

Drug

Primary outcomes

  1. Visual Analog Scale (VAS) Score for Maximum Procedural Pain

    Time frame: Assessed immediately following completion of the procedure (as defined as removal of the speculum)

    To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.

  2. Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])

    Time frame: Assessed 30 minutes after procedure completion.

    The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Society of Family Planning
  • University of Colorado, Denver

Registry information

Acronym: NOVIA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.