Nitrous Oxide Versus Intravenous Sedation for Anesthesia
NOVIA
1 other identifier
interventional
39
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
July 1, 2017
10 months
April 20, 2016
June 15, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Analog Scale (VAS) Score for Maximum Procedural Pain
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])
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.
Study Arms (2)
Nitrous oxide and IV saline
EXPERIMENTALParticipants 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.
Standard Care (IV Sedation and Oxygen)
NO INTERVENTIONWithin 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Mexicolead
- Society of Family Planningcollaborator
- University of Colorado, Denvercollaborator
Study Sites (2)
University of Colorado
Denver, Colorado, 173364, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Related Publications (1)
Thaxton L, Pitotti J, Espey E, Teal S, Sheeder J, Singh RH. Nitrous Oxide Compared With Intravenous Sedation for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1192-1197. doi: 10.1097/AOG.0000000000002915.
PMID: 30303904DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sharla Biefeld Research Coordinator
- Organization
- University of New Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
Rameet Singh, MD, MPH
University of New Mexico Health Sciences Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Family Planning
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 28, 2016
Study Start
July 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-07