Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Not Applicable

Completed

• Conditions: Pregnancy Termination in Second Trimester
• Interventions: Drug: Nitrous Oxide; Drug: IV Saline

• Registration Number: NCT02755090
• Lead Sponsor: University of New Mexico

Brief 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.

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Study Start: 2016-07
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2017-06-15
• Status Verified: 2017-07
• Results First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Results First Posted: 2017-09-15
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrous oxide and IV saline	IV Saline	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.
Nitrous oxide and IV saline	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Score for Maximum Procedural Pain	Assessed immediately following completion of the procedure (as defined as removal of the speculum)	To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.
Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])	Assessed 30 minutes after procedure completion.	The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).

Trial Locations

Locations (2)

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States