Nitrous Oxide Versus Intravenous Sedation for Anesthesia

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of New Mexico
• Collaborators: Society of Family Planning; University of Colorado, Denver
• Treatments: Anesthetics; Ibuprofen; Nitrous Oxide

Criteria

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