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Inhaled Nitrous Oxide and Labor Analgesia

Primary Purpose

Labor Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled nitrous oxide
Sponsored by
Ya'aqov Abrams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Nitrous oxide, labor and delivery, analgesia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Magee-Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitrous Oxide

Arm Description

Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.

Outcomes

Primary Outcome Measures

Labor Pain
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).

Secondary Outcome Measures

Full Information

First Posted
November 17, 2012
Last Updated
October 20, 2017
Sponsor
Ya'aqov Abrams
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01738672
Brief Title
Inhaled Nitrous Oxide and Labor Analgesia
Official Title
Inhaled Nitrous Oxide and Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ya'aqov Abrams
Collaborators
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Nitrous oxide, labor and delivery, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrous Oxide
Arm Type
Experimental
Arm Description
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Intervention Type
Drug
Intervention Name(s)
Inhaled nitrous oxide
Other Intervention Name(s)
N2O, Nitronox, Entonox
Intervention Description
Administration of nitrous oxide for labor analgesia
Primary Outcome Measure Information:
Title
Labor Pain
Description
Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).
Time Frame
At baseline, and at 1 hour after initiation of nitrous oxide
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).
Time Frame
At baseline, and at 1 hour after initiation of nitrous oxide
Title
Nausea
Description
Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).
Time Frame
At baseline, and at 1 hour after initiation of nitrous oxide
Title
Emesis
Description
Participant reported emesis (yes or no).
Time Frame
During administration of nitrous oxide
Title
Participant Satisfaction
Description
Participant reported score of satisfaction with nitrous oxide for labor analgesia, using a numerical rating scale (NRS) ranging from completely dissatisfied (0) to completely satisfied (100).
Time Frame
24 hours after delivery
Title
Crossover To Epidural
Description
Participants crossing over from nitrous oxide to epidural.
Time Frame
Initiation of nitrous oxide to completion of delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya'aqov Abrams, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Inhaled Nitrous Oxide and Labor Analgesia

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