Nitrous Oxide Versus Intravenous Sedation for Anesthesia (NOVIA)

University of New Mexico (UNM) logo

University of New Mexico (UNM)

Status

Completed

Conditions

Pregnancy Termination in Second Trimester

Treatments

Drug: Nitrous Oxide
Drug: IV Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02755090
UNMHSC 16-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

39 participants in 2 patient groups

Nitrous oxide and IV saline
Experimental group
Description:
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.
Treatment:
Drug: IV Saline
Drug: Nitrous Oxide
Standard Care (IV Sedation and Oxygen)
No Intervention group
Description:
Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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