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Comparing Sedara to Butorphanol in Early Labor

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. Identifier: NCT01636999
Recruitment Status : Withdrawn
First Posted : July 10, 2012
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
West Penn Allegheny Health System

Brief Summary:

Nitrous oxide (N2O) has been used for the treatment of labor pains for over 150 years. The longevity of its use in clinical practice can be attributed to its excellent safety profile, ease of administration, and familiarity of use among health-care providers. Sedara is a self-administered 50% N2O, 50% oxygen gas mixture with pain relieving and anxiety reducing properties recently available for use in the United States (US) to treat various painful clnical situations, including labor pains.

In the US, epidural or intravenous administration of narcotic medications is one of the most common and frequently requested treatments for patients experiencing labor pains. Although generally considered safe, complications are common with epidurals, including fetal distress, low blood pressure in the mother, respiratory distress, and headache. In our hospital system, the use of the synthetic intravenous painkiller, Butorphanol, is a mainstay of treatment for labor pains. It too can have undesirable side effects in the mother, including low blood pressure and breathing problems.

Because Sedara has until recently been unavailable in the US, studies comparing its efficacy with other agents for labor pain have been confined to Europe, predominantly in the United Kingdom. Several studies have investigated the efficacy of Sedara versus inhalation and intravenous anesthetics in various countries. We have obtained several Sedara devices for use in the West Penn Allegheny Health System (WPAHS) Department of Anesthesiology and would like to examine its efficacy in our target population of women experiencing pain during early labor.

Hypothesis - Sedara will provide equivalent or superior pain relief among term, adult parturients in early labor (less than 5cm cervical dilation) compared to intravenous butorphanol.

Primary aim - Compare Sedara versus butorphanol in a single-blinded randomized trial with the main outcome measure being reduction in labor pains at various time intervals.

Our findings may be significant in terms of improving safety and efficacy of pain relief among women experienceing labor pains. Given that Sedara has not been previously studied in the US, the results may influence current obstetrical and pain management practices.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: 50% Nitrous Oxide/50% Oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparing Pain Relief in Early Labor: Nitrous Oxide Versus Butorphonol Study
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Butorphanol
The main study arm will be examining how well a 50% Nitrous Oxide/50% Oxygen gas mixture is in reducing labor pains in term labor patients with less than 5 cm cervical dilation, compared to 2mg of Butorphanol (a common synthetic opiod used for labor pains in this setting).
Drug: 50% Nitrous Oxide/50% Oxygen
The gas mixture is provided via the Sedara portable gas delivery system. This system is equipped with a non-rebreather mask which the patient holds over their mouth and nose. The delivery of the gas is only triggered by the patient's spontaneous breath. The gas machine will be provided to the patient to use as much as they like during the 60 minutes data collection period. The only dose which the machine allows to be administered is 50% Nitrous Oxide/50% oxygen.
Other Name: Sedara (FDA 510K Approval No. K101286)

Primary Outcome Measures :
  1. Pain relief [ Time Frame: 60 minutes ]
    The primary outcome measure of pain relief will be measured using a 100mm visual analog scale (VAS) immediately prior to administration of the test medication (either Sedara or butorphanol) and again at 5, 15, 30 and 60 minutes following the medication start time.

Secondary Outcome Measures :
  1. Nausea, Sedation, Satisfaction [ Time Frame: 60 minutes ]
    Secondary outcome measures collected include maternal reported level nausea, sedation, and overall satisfaction with analgesia using the Visual Analog Scores Scale at 0, 5, 15, 30 and 60 minutes.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female
  • 18 years of age or older
  • Presents in active labor
  • Full term pregnancy (at least 37 and up to 42 weeks gestation)
  • Less than 5 cm cervical dilation on exam

Exclusion Criteria:

  • Patients who have received prior regional or opioid analgesia
  • Patients who have taken oral analgesics (narcotic or non-steroidal anti inflammatory drugs) within 6 hours prior to presentation

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 identifier (NCT number): NCT01636999

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United States, Pennsylvania
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 152064231
Sponsors and Collaborators
West Penn Allegheny Health System
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Principal Investigator: Helene Finegold, MD Associate Residency Program Director
Study Chair: Christopher Troianos, MD Residency Program Director

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Responsible Party: West Penn Allegheny Health System Identifier: NCT01636999    
Other Study ID Numbers: 12-007
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by West Penn Allegheny Health System:
Nitrous Oxide
Visual Analog Scale
Additional relevant MeSH terms:
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Labor Pain
Neurologic Manifestations
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents