N/A
N=39
Nitrous Oxide Versus Intravenous Sedation for Anesthesia
Pregnancy Termination in Second Trimester
Bottom Line
View on ClinicalTrials.gov: NCT02755090 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Visual Analog Scale (VAS) Score for Maximum Procedural Pain — 54.1; 34.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nitrous Oxide (Drug); IV Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- May 2017
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 | — |
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.
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
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.