CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Nitrous Oxide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02755090
NCT02755090N/ACompleted
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Nitrous Oxide Versus Intravenous Sedation for Anesthesia

University of New Mexico·interventional·Posted Apr 28, 2016·Updated Sep 15, 2017

In Brief

A clinical study evaluating Nitrous Oxide and IV Saline for Pregnancy Termination in Second Trimester. Completed, enrolled 39 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy Termination in Second Trimester
CountriesUnited States
CollaboratorsSociety of Family Planning, University of Colorado, Denver

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartJul 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago

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