Nitrous Oxide Versus Intravenous Sedation for Anesthesia

University of New Mexico39 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Pregnancy Termination in Second Trimester

Interventions

Nitrous OxideDRUG

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 SalineDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado

Denver, Colorado, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Assessed 30 minutes after procedure completion.

Data from ClinicalTrials.gov

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