Inhaled Nitrous Oxide and Labor Analgesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Manuel C. Vallejo, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01738672
First received: November 17, 2012
Last updated: February 1, 2013
Last verified: February 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Nitrous Oxide and Labor Analgesia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Decreased labor pain [ Time Frame: Throughout labor, nitrous oxide will be administered during contractions. ] [ Designated as safety issue: No ]
    Reduce the need for epidural anesthesia in labor and delivery. Throughout labor, nitrous oxide will be administered during contractions.


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (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

Ages Eligible for Study:   14 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738672

Contacts
Contact: Manuel Vallejo, DMD MD 412-641-4260

Locations
United States, Pennsylvania
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Manuel Vallejo, DMD MD    412-641-4260      
Principal Investigator: Manuel Vallejo, DMD MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Manuel Vallejo, DMD MD Magee-Womens Hospital
  More Information

No publications provided

Responsible Party: Manuel C. Vallejo, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01738672     History of Changes
Other Study ID Numbers: PR011090221
Study First Received: November 17, 2012
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Nitrous oxide
labor and delivery
analgesia

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

ClinicalTrials.gov processed this record on July 22, 2014