Labor PainPhase 2NCT01738672
Inhaled Nitrous Oxide and Labor Analgesia
A Phase 2 study testing Inhaled nitrous oxide in people with Labor Pain, run by Ya'aqov Abrams at 1 site in United States.
Trial summary
Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor epidural anesthesia rate by 15%. Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the provision of labor analgesia at Magee-Womens Hospital. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Inhaled nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2013
- Phase
- Phase 2
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all women of childbearing age (including children aged 14 years and above)who are pregnant
- parturients who request labor analgesia of family medicine investigators certified in the use of nitrous oxide for labor analgesia at Magee-Women's Hospital
- informed verbal and written consent
Who cannot join
- coexisting medical conditions that are contraindications to the use of nitrous oxide (i.e. recent eye or ear surgery, history of Meniere's disease, history of vitamin B-12 deficiency)
- history of severe nausea and vomiting
- history of chronic pain
- inability to hold a facemask
- impairment of consciousness or intoxication at time of delivery
- received intravenous opioids within two hours prior to initiation of nitrous oxide
Show all 10Show fewer
- impaired oxygenation (ex: lung cysts, pneumothorax, pulmonary hypertension, or pulmonary edema) with a room-air pulse oximetry reading less than 95%
- hemodynamic instability
- non-reassuring fetal heart rate tracing
- inability to read, write and understand the English language enough to complete all survey questionnaires and pain assessment scales.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor epidural anesthesia rate by 15%.
Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the provision of labor analgesia at Magee-Womens Hospital.
Read the detailed description
Inhalational anesthetic agents have been used since the mid 1800s to help alleviate pain associated with labor. James Simpson and John Snow initially utilized ether and chloroform respectively in 1847 and 1853. Stanislav Klikovich followed in his predecessors footsteps and successfully administered nitrous oxide for labor analgesia in 1881. Although many inhalational agents have been considered for labor analgesia since that time, the administration of nitrous oxide has been refined over the last century and remains a common practice for obstetrical anesthesia today. Since that time, nitrous oxide has been found to be an effective labor analgesia for many women, although providing less pain relief compared then a labor epidural, it has been found to be safe for the mother, baby, and health care providers.
Nitrous oxide is currently used by 60% of laboring women in the United Kingdom, 50% of women who deliver in Australia and nearly 50% of all parturients in Canada and Finland. This compares to a recent article which reported that only two United States hospitals routinely offer nitrous oxide for labor analgesia as the majority of laboring women request an epidural. The epidural rate in the Unites States averages nearly 90% compared to only 14-38% in other parts of the world.
Nitrous oxide is an easy to administer non-flammable, odorless inhalational agent that produces both analgesia and anxiolysis. It is believed the mechanism of action of nitrous oxide is through the release of endogenous opioid peptides into the periaqueductal gray area of the midbrain which stimulates descending noradrenergic pathways resulting in analgesia. These pathways modulate pain in the dorsal horn of the spinal cord through alpha-2 adrenoreceptors. Anxiolytic effects are thought to be caused by inhibition of N-methyl-D-aspartate (NMDA) receptors. In a Swedish study involving 1,997 parturients utilizing inhaled nitrous oxide as the sole anesthetic for labor analgesia, 37.6% of participants reported effective pain relief.
Currently, the rate of labor epidural analgesia at Magee Womens Hospital is approximately 90%. There are many advantages to the use of nitrous oxide for labor analgesia compared to an epidural. Complications associated with labor epidural analgesia can include infection, bleeding, headache, and wet-tap. These complications can result in a prolonged hospital stay that is not associated with the use of nitrous oxide for labor analgesia.
One of the biggest advantages of the use of nitrous oxide for labor analgesia is the significantly lower cost to administer compared to an epidural. In a recent article in the Birth journal, it was noted that the use of nitrous oxide is far less expensive and much simpler than epidural analgesia and does not result in complications requiring additional treatments and prolonged hospital stays. The use of nitrous could have major financial benefits for both Medicaid and private insurance companies. In 2004, the largest cost for these insurance entities was the cost to care for pregnant and laboring women which was reported to cost $41 billion. The most significant cost savings would be the reduction in anesthesia services. Currently average cost per patient for anesthesia staff coverage is 728 dollars. Average re-imbursement for a labor epidural placement is 385 dollars. Nitrous oxide does not require anesthesia staff to implement, saving health care dollars. After the initial investment of the nitrous oxide machine, the only additional cost would be the tubing and mask for the patient and the nitrous oxide and oxygen E-cylinders for delivery.
With Nitrous oxide having many qualities that make it an attractive choice for labor analgesia, many anesthesia providers are questioning its limited use in the United States. It is speculated that it may be cultural issue and that women make decisions regarding labor analgesia based on learned experiences of family and friends, many of whom have not heard of or used nitrous oxide to cope with labor pains. Another reason may be that some authors argue that nitrous oxide is an orphan drug with no pizzazz for professional groups or companies to profit from its use as it causes environmental and occupational hazards which limit its use. No definitive opinion exists to answer this question. Finally, some authors suggest its use is limited due to the disadvantages of nitrous oxide, which include the possibility to cause mood alterations, euphoria, impaired mentation, dysphoria, inappropriate behaviors and nausea and vomiting. These side effects are limited through a number of fail-safe mechanisms built into the nitrous oxide machine which includes the delivery of at least 30% oxygen and 3 liters of fresh gas flow. In addition the proper use includes self administration under direct supervision of a trained provider while the nitrous oxide is in use.
- Conditions
- Labor Pain
- Being tested
- Inhaled nitrous oxide
- Keywords
- Nitrous oxide, labor and delivery, analgesia
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitrous oxideDrug
Also called N2O, Nitronox, Entonox
Administration of nitrous oxide for labor analgesia
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide | Experimental | Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia. Receives: Drug: Inhaled nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Pain
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
Measured: At baseline, and at 1 hour after initiation of nitrous oxide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
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.
- Other trials for Labor PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ya'aqov Abrams
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor-investigator, Ya'aqov Abrams, University of Pittsburgh
- Investigators
- Ya'aqov Abrams, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738672
- Sponsor's protocol ID
- PRO11090221
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2012
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitrous Oxide and Labor Analgesia
- ClinicalTrials.gov ID
- NCT01738672
- Acronym / sponsor ID
- PRO11090221
- Conditions
- Labor Pain
- Keywords
- Nitrous oxide, labor and delivery, analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ya'aqov AbramsUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 21 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor epidural anesthesia rate by 15%.
Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the provision of labor analgesia at Magee-Womens Hospital.
Detailed description
Inhalational anesthetic agents have been used since the mid 1800s to help alleviate pain associated with labor. James Simpson and John Snow initially utilized ether and chloroform respectively in 1847 and 1853. Stanislav Klikovich followed in his predecessors footsteps and successfully administered nitrous oxide for labor analgesia in 1881. Although many inhalational agents have been considered for labor analgesia since that time, the administration of nitrous oxide has been refined over the last century and remains a common practice for obstetrical anesthesia today. Since that time, nitrous oxide has been found to be an effective labor analgesia for many women, although providing less pain relief compared then a labor epidural, it has been found to be safe for the mother, baby, and health care providers.
Nitrous oxide is currently used by 60% of laboring women in the United Kingdom, 50% of women who deliver in Australia and nearly 50% of all parturients in Canada and Finland. This compares to a recent article which reported that only two United States hospitals routinely offer nitrous oxide for labor analgesia as the majority of laboring women request an epidural. The epidural rate in the Unites States averages nearly 90% compared to only 14-38% in other parts of the world.
Nitrous oxide is an easy to administer non-flammable, odorless inhalational agent that produces both analgesia and anxiolysis. It is believed the mechanism of action of nitrous oxide is through the release of endogenous opioid peptides into the periaqueductal gray area of the midbrain which stimulates descending noradrenergic pathways resulting in analgesia. These pathways modulate pain in the dorsal horn of the spinal cord through alpha-2 adrenoreceptors. Anxiolytic effects are thought to be caused by inhibition of N-methyl-D-aspartate (NMDA) receptors. In a Swedish study involving 1,997 parturients utilizing inhaled nitrous oxide as the sole anesthetic for labor analgesia, 37.6% of participants reported effective pain relief.
Currently, the rate of labor epidural analgesia at Magee Womens Hospital is approximately 90%. There are many advantages to the use of nitrous oxide for labor analgesia compared to an epidural. Complications associated with labor epidural analgesia can include infection, bleeding, headache, and wet-tap. These complications can result in a prolonged hospital stay that is not associated with the use of nitrous oxide for labor analgesia.
One of the biggest advantages of the use of nitrous oxide for labor analgesia is the significantly lower cost to administer compared to an epidural. In a recent article in the Birth journal, it was noted that the use of nitrous oxide is far less expensive and much simpler than epidural analgesia and does not result in complications requiring additional treatments and prolonged hospital stays. The use of nitrous could have major financial benefits for both Medicaid and private insurance companies. In 2004, the largest cost for these insurance entities was the cost to care for pregnant and laboring women which was reported to cost $41 billion. The most significant cost savings would be the reduction in anesthesia services. Currently average cost per patient for anesthesia staff coverage is 728 dollars. Average re-imbursement for a labor epidural placement is 385 dollars. Nitrous oxide does not require anesthesia staff to implement, saving health care dollars. After the initial investment of the nitrous oxide machine, the only additional cost would be the tubing and mask for the patient and the nitrous oxide and oxygen E-cylinders for delivery.
With Nitrous oxide having many qualities that make it an attractive choice for labor analgesia, many anesthesia providers are questioning its limited use in the United States. It is speculated that it may be cultural issue and that women make decisions regarding labor analgesia based on learned experiences of family and friends, many of whom have not heard of or used nitrous oxide to cope with labor pains. Another reason may be that some authors argue that nitrous oxide is an orphan drug with no pizzazz for professional groups or companies to profit from its use as it causes environmental and occupational hazards which limit its use. No definitive opinion exists to answer this question. Finally, some authors suggest its use is limited due to the disadvantages of nitrous oxide, which include the possibility to cause mood alterations, euphoria, impaired mentation, dysphoria, inappropriate behaviors and nausea and vomiting. These side effects are limited through a number of fail-safe mechanisms built into the nitrous oxide machine which includes the delivery of at least 30% oxygen and 3 liters of fresh gas flow. In addition the proper use includes self administration under direct supervision of a trained provider while the nitrous oxide is in use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide | Experimental | Drug: Inhaled nitrous oxideParturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- all women of childbearing age (including children aged 14 years and above)who are pregnant
- parturients who request labor analgesia of family medicine investigators certified in the use of nitrous oxide for labor analgesia at Magee-Women's Hospital
- informed verbal and written consent
Key exclusion criteria (10 listed)
- coexisting medical conditions that are contraindications to the use of nitrous oxide (i.e. recent eye or ear surgery, history of Meniere's disease, history of vitamin B-12 deficiency)
- history of severe nausea and vomiting
- history of chronic pain
- inability to hold a facemask
- impairment of consciousness or intoxication at time of delivery
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 |
|---|---|---|
| Inhaled nitrous oxideAlso: N2O, Nitronox, EntonoxAdministration of nitrous oxide for labor analgesia | Drug | Nitrous Oxide |
Primary outcome
Labor Pain
Time frame: At baseline, and at 1 hour after initiation of nitrous oxide
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ya'aqov Abrams, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled nitrous oxide in people with Labor Pain, run by Ya'aqov Abrams 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 Nov 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 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?
Labor Pain (time frame: At baseline, and at 1 hour after initiation of nitrous oxide). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2017.