Abortion in First TrimesterNABNCT02096575
Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
A study testing Nitrous oxide administration in people with Abortion in First Trimester, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications. 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
- Abortion in First Trimester
- What is being tested?
- Nitrous oxide administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2015
- 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,
- elective pregnancy termination at gestational age of less than 11 weeks,
- speak English
- candidate for an in-clinic procedure.
- desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain
Who cannot join
- no medical problems preventing the use of nitrous oxide
- no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
- significant active upper respiratory infection
- chronic obstructive pulmonary disease (COPD)
- intoxication
- use of street drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.
Read the detailed description
This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.
- Conditions
- Abortion in First Trimester
- Being tested
- Nitrous oxide administration
- Keywords
- nitrous oxide, 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 oxide administrationOther
All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. The NO group will get two placebo pills and the standard care group will get one 5/325 mg Vicodin, and 1 mg of Ativan 30 minutes before the procedure. The standard care group will get oxygen intraoperatively.
NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention.
All patients will get local anesthesia via a standardized PCB.
| Study group | Role | What they receive |
|---|---|---|
| Nitrous oxide administration | Experimental | All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.
In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously. Receives: Other: Nitrous oxide administration |
| Standard care group | No intervention | All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score for Mean Maximum Procedural Pain
The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.
Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Measured: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure
Secondary outcomes (4)
Visual Analog Scale Score for Baseline Pain
A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Measured: Baseline pain assessment on average within 30 minutes before procedure
Visual Analog Scale for Post-procedure Pain
A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Measured: Visual analog scale administered on average 20 minutes after procedure completed
Pain Management Satisfaction
Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Measured: Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.
Visual Analog Scale to Measure Anticipated Pain.
Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Measured: Anticipated pain assessed on average within 30 minutes before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
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 Abortion in First 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rameet Singh, University of New Mexico
- Investigators
- Rameet H. Singh, MD, MPH, Principal investigator, University of New Mexico Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096575
- Sponsor's protocol ID
- UNMHSC12-313
- Acronym
- NAB
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2014
- Last updated
- 19 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Singh RH, Espey E, Carr S, Pereda B, Ogburn T, Leeman L. Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study. Contraception. 2015 Feb;91(2):164-6. doi: 10.1016/j.contraception.2014.09.013. Epub 2014 Oct 22.
PubMed 25459096
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT02096575
- Acronym / sponsor ID
- NAB / UNMHSC12-313
- Conditions
- Abortion in First Trimester
- Keywords
- nitrous oxide, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 11 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.
Detailed description
This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide administration | Experimental | Other: Nitrous oxide administrationAll participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously. |
| Standard care group | No intervention | –All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older,
- elective pregnancy termination at gestational age of less than 11 weeks,
- speak English
- candidate for an in-clinic procedure.
- desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain
Key exclusion criteria (6 listed)
- no medical problems preventing the use of nitrous oxide
- no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
- significant active upper respiratory infection
- chronic obstructive pulmonary disease (COPD)
- intoxication
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 oxide administrationAll participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. The NO group will get two placebo pills and the standard care group will get one 5/325 mg Vicodin, and 1 mg of Ativan 30 minutes before the procedure. The standard care group will get oxygen intraoperatively. NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention. All patients will get local anesthesia via a standardized PCB. | Other | Nitrous oxide administration |
Primary outcome
Visual Analog Pain Score for Mean Maximum Procedural Pain
Time frame: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure
The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
4 secondary outcomes
Visual Analog Scale Score for Baseline Pain
Time frame: Baseline pain assessment on average within 30 minutes before procedure
Visual Analog Scale for Post-procedure Pain
Time frame: Visual analog scale administered on average 20 minutes after procedure completed
Pain Management Satisfaction
Time frame: Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.
Visual Analog Scale to Measure Anticipated Pain.
Time frame: Anticipated pain assessed on average within 30 minutes before procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25459096Singh RH, Espey E, Carr S, Pereda B, Ogburn T, Leeman L. Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study. Contraception. 2015 Feb;91(2):164-6. doi: 10.1016/j.contraception.2014.09.013. Epub 2014 Oct 22.
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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 H. Singh, MD, MPH principal investigator
University of New Mexico Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous oxide administration in people with Abortion in First Trimester, run by University of New Mexico at 1 site 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 5 inclusion and 6 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Mar 2016). 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 Pain Score for Mean Maximum Procedural Pain (time frame: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure). 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 NCT02096575, 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 19 Apr 2016.