Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Pregnancy Termination in Second Trimester Clinical Trial

— NOVIA  

Official title:

Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755090
• Other study ID #: UNMHSC 16-101
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: May 22, 2017
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Termination in Second Trimester

Intervention

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.
• IV Saline

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Colorado	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of New Mexico	Society of Family Planning, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Score for Maximum Procedural Pain	To compare women's maximum procedural pain measured on a visual analog scale 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.	Assessed immediately following completion of the procedure (as defined as removal of the speculum)
Primary	Satisfaction with Anesthesia (Iowa Satisfaction with Anesthesia Scale [ISAS])	To compare women's satisfaction with procedural pain management measured on the Iowa Satisfaction with Anesthesia Scale (ISAS) following a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation.	Assessed 30 minutes after procedure completion.