We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inhaled Nitrous Oxide and Labor Analgesia

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738672
First Posted: November 30, 2012
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Ya'aqov Abrams, University of Pittsburgh
  Purpose

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.


Condition Intervention Phase
Labor Pain Drug: Inhaled nitrous oxide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Nitrous Oxide and Labor Analgesia

Resource links provided by NLM:


Further study details as provided by Ya'aqov Abrams, University of Pittsburgh:

Primary Outcome Measures:
  • 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).


Other Outcome Measures:
  • Anxiety [ Time Frame: At baseline, and at 1 hour after initiation of nitrous oxide ]
    Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).

  • Nausea [ Time Frame: At baseline, and at 1 hour after initiation of nitrous oxide ]
    Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).

  • Emesis [ Time Frame: During administration of nitrous oxide ]
    Participant reported emesis (yes or no).

  • Participant Satisfaction [ Time Frame: 24 hours after delivery ]
    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).

  • Crossover To Epidural [ Time Frame: Initiation of nitrous oxide to completion of delivery. ]
    Participants crossing over from nitrous oxide to epidural.


Enrollment: 16
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nitrous Oxide
Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.
Drug: Inhaled nitrous oxide
Administration of nitrous oxide for labor analgesia
Other Names:
  • N2O
  • Nitronox
  • Entonox

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738672


Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Ya'aqov Abrams
University of Pittsburgh
Investigators
Principal Investigator: Ya'aqov Abrams, MD Magee-Womens Hospital
  More Information

Responsible Party: Ya'aqov Abrams, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01738672     History of Changes
Other Study ID Numbers: PRO11090221
First Submitted: November 17, 2012
First Posted: November 30, 2012
Results First Submitted: October 20, 2017
Results First Posted: November 21, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017

Keywords provided by Ya'aqov Abrams, University of Pittsburgh:
Nitrous oxide
labor and delivery
analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Physiological Effects of Drugs
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents