N/A Completed N=39 Randomized Triple-blind Other

Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Pregnancy Termination in Second Trimester

Source: ClinicalTrials.gov NCT02755090 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcomePrimary: Visual Analog Scale (VAS) Score for Maximum Procedural Pain — 54.1; 34.0 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scale (VAS) Score for Maximum Procedural Pain	54.1; 34.0	—
PRIMARY Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])	0.7; 1.8	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT02755090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.