Nitrous Oxide Versus Intravenous Sedation for Anesthesia (NOVIA)

August 17, 2017 updated by: Rameet Singh, University of New Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 173364
        • University of Colorado
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nitrous oxide and IV saline
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.
Drug: IV Saline
Drug: Nitrous Oxide
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.
NO_INTERVENTION: Standard Care (IV Sedation and Oxygen)
Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed immediately following completion of the procedure (as defined as removal of the speculum)
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).
Assessed 30 minutes after procedure completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

University of Colorado, Denver
Society of Family Planning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (ESTIMATE)

April 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNMHSC 16-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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