Nitrous Oxide Versus Intravenous Sedation for Anesthesia
NCT ID: NCT02755090
Last Updated: 2017-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2016-07-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Nitrous oxide and 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
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.
IV Saline
Standard Care (IV Sedation and Oxygen)
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.
No interventions assigned to this group
Interventions
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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.
IV Saline
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of Colorado, Denver
OTHER
University of New Mexico
OTHER
Responsible Party
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Rameet Singh
Chief, Division of Family Planning
Principal Investigators
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Rameet Singh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico Health Sciences Center
Locations
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University of Colorado
Denver, Colorado, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Countries
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References
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Thaxton L, Pitotti J, Espey E, Teal S, Sheeder J, Singh RH. Nitrous Oxide Compared With Intravenous Sedation for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1192-1197. doi: 10.1097/AOG.0000000000002915.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UNMHSC 16-101
Identifier Type: -
Identifier Source: org_study_id