Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nitrous Oxide Versus Intravenous Sedation for Anesthesia

Conditions
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Pregnancy Termination in Second Trimester

Intervention / Treatment
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* Drug: Nitrous Oxide
* Drug: IV Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrous oxide and IV saline<br>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. | Drug: Nitrous Oxide<br>* 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.<br>Drug: IV Saline<br> <br> |
| No Intervention: Standard Care (IV Sedation and Oxygen)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Score for Maximum Procedural Pain | 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. | Assessed immediately following completion of the procedure (as defined as removal of the speculum) | 
| Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS]) | 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). | Assessed 30 minutes after procedure completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitrous, pain