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Nitrous Oxide Versus Intravenous Sedation for Anesthesia

NCT02755090 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-09-15

Study results available
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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.

Conditions

  • Pregnancy Termination in Second Trimester

Interventions

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.

DRUG

IV Saline

Sponsors & Collaborators

  • Society of Family Planning

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of New Mexico

    lead OTHER

Principal Investigators

  • Rameet Singh, MD, MPH · University of New Mexico Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755090 on ClinicalTrials.gov