Inhaled Nitrous Oxide and Labor Analgesia

NCT01738672 | Terminated Phase 2 Results DMC

• 1 other identifier: PRO11090221
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Nitrous oxide; labor and delivery; analgesia

Outcome Measures

Primary Outcomes (1)

• Labor Pain

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

  At baseline, and at 1 hour after initiation of nitrous oxide

Other Outcomes (5)

• Anxiety

  At baseline, and at 1 hour after initiation of nitrous oxide

• Nausea

  At baseline, and at 1 hour after initiation of nitrous oxide

• Emesis

  During administration of nitrous oxide

Study Arms (1)

Nitrous Oxide

EXPERIMENTAL

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

Drug: Inhaled nitrous oxide

Interventions

Inhaled nitrous oxide DRUG

Administration of nitrous oxide for labor analgesia

Also known as: N2O, Nitronox, Entonox

Nitrous Oxide

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ya'aqov Abrams: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Entonox

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

The study was limited by its small size. Additionally, because all participants were recruited from Family Medicine clinics in Pittsburgh, these results may not be generalizable to other populations of pregnant women.

Results Point of Contact

• Title: Ya'aqov Abrams, MD
• Organization: University of Pittsburgh

abramsym@upmc.edu

Study Officials

• Ya'aqov Abrams, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 21, 2017
• Results First Posted: November 21, 2017

Record last verified: 2017-10

Locations

US (1)