Pregnancy Termination in Second TrimesterNOVIANCT02755090
Nitrous Oxide Versus Intravenous Sedation for Anesthesia
A study testing Nitrous Oxide and IV Saline in people with Pregnancy Termination in Second Trimester, run by University of New Mexico at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Termination in Second Trimester
- What is being tested?
- Nitrous Oxide and IV Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
University of Colorado
Denver, Colorado, 173364
About this study
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.
Read the 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.
- Being tested
- Nitrous Oxide, IV Saline
- Keywords
- nitrous, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
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 SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nitrous oxide and IV saline | Experimental | 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. Receives: Drug: Nitrous Oxide; Drug: IV Saline |
| Standard Care (IV Sedation and Oxygen) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Assessed 30 minutes after procedure completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Termination in Second TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning, University of Colorado, Denver
- Responsible party
- Principal investigator, Rameet Singh, University of New Mexico
- Investigators
- Rameet Singh, MD, MPH, Principal investigator, University of New Mexico Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755090
- Sponsor's protocol ID
- UNMHSC 16-101
- Acronym
- NOVIA
- Status last verified
- Jul 2017
- First submitted
- 20 Apr 2016
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30303904
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide Versus Intravenous Sedation for Anesthesia
- ClinicalTrials.gov ID
- NCT02755090
- Acronym / sponsor ID
- NOVIA / UNMHSC 16-101
- Keywords
- nitrous, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Society of Family Planning, University of Colorado, Denver
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 15 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide and IV saline | Experimental | Drug: Nitrous Oxide, Drug: IV SalineParticipants 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. |
| Standard Care (IV Sedation and Oxygen) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous OxideParticipants 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 and IV saline |
| IV Saline | Drug | Nitrous oxide and IV saline |
Primary outcome
Visual Analog Scale (VAS) Score for Maximum Procedural Pain
Time frame: 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])
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30303904Thaxton 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.
Related trials for Pregnancy Termination in Second Trimester
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Not yet recruitingObservational study
Misoprostol in Missed Abortion
Abortion; Attempted
Not yet recruitingObservational study
Comparative Psychiatric Problems Between First and Second Trimester Miscarriage
Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rameet Singh, MD, MPH principal investigator
University of New Mexico Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous Oxide and IV Saline in people with Pregnancy Termination in Second Trimester, run by University of New Mexico at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Score for Maximum Procedural Pain (time frame: Assessed immediately following completion of the procedure (as defined as removal of the speculum)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.