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10/14/2015

Nitrous Oxide

Katherine Todd, DNP, RNC, PHN

Disclosure Statement

I have no financial, personal, professional, political, institutional, or other biases related to the use of to declare.

Now it’s time for YOU to disclose

By a show of hands…

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Objectives

• Discuss the purpose of utilizing mild via self-administered inhaled nitrous oxide delivery system for women in the intrapartum/immediate postpartum period.

• Recognize the uses of patient controlled nitrous oxide as an analgesic/anxiolytic and the current practices and guidelines to providing safe and consistent administration.

• Identify and discuss steps and approaches to acquiring organizational support and partnership in order to implement patient-administered nitrous oxide into a hospital obstetrical setting.

Together we had a dream to…

• Offer a safe rapid delivery system for pain relief. • Empower woman to have a sense of control over her situation. • Educate staff to be competent and comfortable with the safe use of Nitrous Oxide. • Maintain our reputation for offering safe, natural and cutting edge birth options for our families.

Methodist Hospital became the first in Minnesota to offer Nitrous in May of 2015

• Purchased 6 units to ensure adequate availability as demand increases in line with public awareness.

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What is Nitrous Oxide?

• N2O is a nonflammable, odorless gas that is liquid at room temperature. • Mechanism of action is not well understood but it’s believed to stimulate the release of endogenous endorphins and possibly, corticotropins and dopamine release as well (Nursing for Women’s Health, Oct/Nov 2012.) • These biochemical actions create a euphoric effect that makes the patient less aware of pain (Rosen, 2002).

Why Now? • Patient interest has been peaked by the recent news coverage introducing patients to nitrous oxide as a viable pain relief option. • Safety has been established: N2O+O2 is the most widely used labor analgesia in the developed world, including use in countries with better maternal and newborn mortality indices than the USA. • The World Health Organization (WHO), in a 2013 report, includes nitrous oxide as one of the 100 most useful in the world. • Cost effective= After the initial expense of acquiring the necessary equipment, N2O+O2 is inexpensive to use. • Ease of use for staff = Both to set up and teach patient proper technique. • Ease of use for patient = Self administration is uncomplicated. (Reference page)

PURPOSE : To provide mild analgesia via a self-administered inhaled nitrous oxide delivery system for women in the intrapartum/immediate postpartum period.

• External cephalic version and/or other painful procedures • Labor analgesia and anxiolytic • Difficult vaginal exams • While awaiting epidural placement (lesson learned) • Forceps or vacuum assisted deliveries • Perineal/vaginal repair • Manual removal of placenta • IV starts • Post delivery catheterization • IUFD (bedside D&C)

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Benefits • Safe for mom and baby, no respiratory in newborn and so can be used at any point in labor-it’s never too late. • Onset of pain relief and decreased is usually within 30-60 seconds of inhalation • Half life of approximately 5 minutes. Patients can feel free of effects within 60 seconds of ceasing inhalation. • It allows the woman freedom to continue to labor in any position she chooses. • Nothing to prolong labor- doesn’t space contractions or diminish pushing efforts. • No adverse effect on fetal acid-base balance or Apgar scores. • Not an impediment to initial breastfeeding efforts

(Reference page)

General Information

• For the purpose of our maternity patients the dosage proposed is 50-50 nitrous oxide and oxygen mix in a self-administering form, relegating it to the classification of a mild sedation and NOT dispensation of an . • N2O+O2 use is no different than nurses, nurse midwives and physicians continuing to monitor women who receive per established guidelines. • It is short acting and excreted though the lungs. • Does not cause respiratory depression in mother or baby.

Contraindications 1. Patients who cannot hold their own facemask. 2. Patients who are acutely intoxicated or have impaired consciousness. 3. Patients who have received opioids in the last two hours. Opioids may be administered 15 minutes after cessation of nitrous oxide use. 4. Patients with pernicious anemia or documented B12 deficiency Note: Patients taking B12 as a nutritional supplement without a deficiency are not contraindicated from this therapy. 5. Patients with a history of pneumothorax, bowel obstruction, increased intra-cranial pressure or intra-ocular surgery might not be candidates for nitrous oxide and will be assessed by the ordering provider for appropriateness of therapy. 6. Labor/bath tub: may not use nitrous oxide while in the tub. 7. If at any time there is concern for maternal or fetal well-being, nitrous oxide therapy may be discontinued at the discretion of the care provider-MD, CNM or RN.

8. Patients receiving Methadone or Suboxone are ruled out for nitrous oxide use. (Reference page)

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• In 2010, only 4 US hospitals were using nitrous oxide on OB units. • Since 2011, after the FDA approval of new equipment, there are now 60+ facilities including hospitals and birth centers nation- wide. • Several Minnesota birth centers have recently implemented nitrous oxide, but hospital based birth centers have been slower to implement.

Who needed to support?

• CNO, CMO & CFO • OB Council • Operations Council • Credentialing Committee • Risk Management • Pharmacy Committee • Pain Committee • Anesthesia Department • Clinical Documentation Subcommittee • Employee and Occupational Health • Safety and Security Director

Financial Discussion

PRO-NOX mixer, 6' high-pressure O2 and N2O hoses, manual, and one disposable pt. circuit. 2-year warranty on device. CMI-0100-PNX 1 6 ea 3,998.00 Implementing 6 Nitrous machines

5-castered rolling stand with handle, basket, holder for one O2 and total cost was ~ $37,000.00. one N2O e-cylinder, and tilting pole-top head with stainless steel adaptor plate for attaching PRO-NOX unit. 5-yr warranty CMI-0110A-PNX 2 6 ea 1,198.00

Active Scavenging System with over-pressure and under-pressure relief valves. GD-1925 3 6 ea 899.00 Delivery cost per patient is generally

O2 Regulator high flow 60 PSI reg in the range of $20. O1R001010-B 4 6 ea 182.00

N2O Regulator high flow 60 psi reg O1RN09N10-B 5 6 ea 182.00

Pro-Nox Small Disposable Kit (20 in box) PROSMLKIT 6 1 EA 339.00 ROI: Improved patient satisfaction, PRO-NOX Medium Disposable Kits increased market share, decreased PROMEDKIT 7 4 ea 339.80 cost of other interventions and PRO-NOX Large Disposable Kits PROLRGKIT 8 1 ea 339.80 complications. Currently collecting data to study full impact. Total $36,917.40

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50% Nitrous Oxide is NOT Anesthesia… It is Analgesia

• It is completely patient administered- if she cannot hold the mask/mouth piece herself she cannot use it. • She remains lucid and awake • She does not lose her laryngeal reflexes and so is not at risk of losing her airway. • Her level of analgesia is regulated by the strength and frequency of her respirations. • The equipment can only deliver a mix of 50% Nitrous-50% oxygen-it is not designed as a titratable system.

Credentialing approval determined a DOP is not necessary:

PATIENT CONTROLLED NITROUS OXIDE MILD SEDATION Qualifications To be eligible for special privileges to provide in-house supervision of trained personnel in the administration of patient controlled nitrous oxide mild sedation, the applicant must meet the following qualifications: MD, DO, CNM For monitoring and supporting patients utilizing self-controlled nitrous oxide mild sedation: RN and Current certification in Basic Life Support (BLS) for Health Professionals, and Written documentation of completion of Methodist Hospital approved training in patient controlled nitrous oxide mild sedation.

Documentation

• Ordering care provider must place nitrous oxide order into the electronic medical record. • Ordering provider must be readily available during administration. • Informed consent (verbal) is obtained. • Registered nurse to monitor vital signs, fetal heart tone status and document according to nursing assessment policy. • User Agreement must be signed.

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PATIENT CONTROLLED NITROUS OXIDE AGREEMENT FOR USE This agreement is for the safe use of patient controlled nitrous oxide during labor. By signing this document, I agree to the following:

I understand that the use of patient controlled nitrous oxide is prescribed for my use only. I agree that I will hold my own nitrous oxide mask/mouthpiece (patient controlled). I agree that no other person will hold my nitrous oxide mask/mouthpiece for me. I agree that this is a prescribed that has been prescribed exclusively for me. I understand that no other person (s) are allowed to test, try or use the nitrous oxide.

I understand the unauthorized use of nitrous oxide by others in the room is prohibited.

If anyone other than myself uses my nitrous oxide with or without my approval the nitrous oxide will be immediately removed from my room, and those who are not prescribed trespassed from Park Nicollet Methodist Hospital and subject to criminal charges under MN Statute 609.684.

Education Process

All OB care providers and labor and delivery registered nursing staff receive education and competency verification on use of patient controlled mild nitrous oxide for pain control prior to ordering/dispensing this intervention.

Require providers (CNMs, MDs/Dos) and registered nurses who work in maternity care to complete a CE on nitrous oxide use as labor analgesia.

Webex on our learning site, video, AWHONN article and test required. In-service with machine encouraged.

Is it safe for staff?

• Dual waste gas scavenging always utilized • Environmental exposure is monitored • Proper patient instruction and usage of the unit will ensure minimal environmental exposure. • Routine machine safety checks will be performed. • Monitoring data from UCSF L/D has consistently shown extremely low values of ambient nitrous

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Safety & Security

1. The portable nitrous oxide machine is equipped with a scavenging device and a demand valve. Flow through the unit into the mask occurs only during active inhalation and exhalation. Exhaled gas enters the scavenging device which is attached to wall suction. 2. Nitrous delivery equipment is inspected by the Biomedical department on a routine schedule. Periodic gas monitoring is performed in accordance with current biomedical schedule. 3. Nitrous oxide will be carefully managed and limited to specific personnel and the portable nitrous oxide tanks are secured and the key is located in the Pyxis machine (diversion deterrent).

Equipment Lessons Learned…

• O2 tanks running out • Immediate need for back up Nitrous tank • Regulator valve replacement

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Patient Education Important

• Education begins in the clinics, on tours and in prenatal classes. • Counsel on possible side effects-, dizziness, dysphoria • Patient may move about, with assistance readily available • Proper mask placement to create a good seal around the face • Time breaths to contractions- she needs to begin deep breathing at least 30 seconds before onset of contraction

• A mouth piece and mask are available per patient preference • The patient must inhale and exhale into the device • Instruct that nitrous oxide use will be suspended from time of birth to cutting of umbilical cord • Patients may need ongoing coaching with timing of breaths

• Some women may need to initiate deep breathing of nitrous earlier than 30 sec prior to contractions to optimize pain relief

• Dysphoria: counsel and offer reassurance. If a patient does not like how N20 makes them feel they can take a few deep breaths and the side effects will clear

• Occasionally a woman may need to discontinue use due to side effects

Important to insure realistic patient expectations…

• This is not for patients that desire complete pain relief • Can cause a feeling of dysphoria-some patients may not tolerate it. • May cause nausea. • Mobility is limited by the length of the administration tubing. • Need stand by assist for ambulation as patient may be dizzy. • The patient must not have had in the previous 2 hours.

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What we know 4 months into the journey…

• Nitrous is a great option for many laboring women • Many women desire and deeply appreciate this option • Some women will not tolerate it because of the side effects • Nitrous can be a useful tool in helping patients who desire a less-medicated birth • Nitrous can provide pain relief for bedside procedures requiring analgesia or conscious sedation • Conversion to an epidural is not considered a failure, many women will utilize both options

Questions?

[email protected]

Katherine Todd Methodist Hospital Clinical Nursing Director

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References

ACNM Publication, Position Statement: Nitrous Oxide for Labor Analgesia, ACNM December 2009 Bricker L, Lavender T, Parenteral Opioids for Labor Pain Relief: A Systematic Review, Am J Obstet Gynecol 186:5 May 2002 S94-S109. Bishop, Judith. Administration of Nitrous Oxide in Labor: Expanding the Options. Journal of Midwifery and Women’s Health 52(3) May/June 2007 pp 308-309. Tveit TO, Halvorsen A, Rosland JH, Analgesia for labour: a survey of Norwegian practice-with a focus on parenteral opioids. Acta Anaesthesiol Scand 2009, 53 794-799 Australian Institute of Health and Welfare, Australia’s Mothers and Babies 2008, Perinatal Rosen, Mark. Nitrous Oxide for relief of labor pain: A systematic review. Am J Obstet Gynecol 186(5) 110-127. Carstoniu MA et al, “Nitrous oxide in early labor,” Anesthesiology 80:30-35, 1994. VUMC Area Specific Policy Manual. Accessed June 9, 2011, via https://mcapps.mc.vanderbilt.edu/E-Manual/Hpolicy.nsf Labor & Delivery Policy Manual.AS 21111-20.01 Fetal Heart Rate Monitoring Volmanen P, Akural E, Raudaskoski T, Ohtonen P, Alahuhta S, Comparison of remifentanyl and nitrous oxide in labour analgesia. Acta Anaesthesiol Scand

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