Nitrous Oxide Versus Intravenous Sedation for Anesthesia (NOVIA)

University of New Mexico (UNM)

Status: Completed

Conditions: Pregnancy Termination in Second Trimester

Treatments: Drug: Nitrous Oxide; Drug: IV Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02755090

UNMHSC 16-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups

Nitrous oxide and IV saline

Experimental group

Description:

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.

Treatment:

Drug: IV Saline

Drug: Nitrous Oxide

Standard Care (IV Sedation and Oxygen)

No Intervention group

Description:

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.