NCT02755090

Nitrous Oxide Versus Intravenous Sedation for Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pregnancy Termination in Second Trimester

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-04-28
• Last updated: 2017-09-15
• Results posted: 2017-09-15

Locations

2 sites across 1 country: United States