Comparing Sedara to Butorphanol in Early Labor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by West Penn Allegheny Health System.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Mete Akin, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01636999
First received: July 6, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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 Intervention
Labor Pain
Drug: 50% Nitrous Oxide/50% Oxygen

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparing Pain Relief in Early Labor: Nitrous Oxide Versus Butorphonol Study

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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:
  • Nausea, Sedation, Satisfaction [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01636999

Contacts
Contact: Helene Finegold, MD 412-578-5323 HFinegol@wpahs.org
Contact: Mete Akin, DO, MPH 786-246-1758 makin@wpahs.org

Locations
United States, Pennsylvania
West Penn Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 152064231
Contact: Mete Akin, DO, MPH    786-246-1758    makin@wpahs.org   
Contact: Helene Finegold, MD    412-578-5323    HFinegol@wpahs.org   
Sub-Investigator: Mete Akin, DO, MPH         
Principal Investigator: Helene Finegold, MD         
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Helene Finegold, MD Associate Residency Program Director
Study Chair: Christopher Troianos, MD Residency Program Director
  More Information

Publications:

Responsible Party: Mete Akin, Anesthesiology Resident, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01636999     History of Changes
Other Study ID Numbers: 12-007
Study First Received: July 6, 2012
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by West Penn Allegheny Health System:
Sedara
Nitrous Oxide
Butorphanol
Visual Analog Scale

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

ClinicalTrials.gov processed this record on October 23, 2014