Comparing Sedara to Butorphanol in Early Labor
Primary Purpose
Labor Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50% Nitrous Oxide/50% Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Sedara, Nitrous Oxide, Butorphanol, Visual Analog Scale
Eligibility 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
Sites / Locations
- West Penn Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Butorphanol
Arm Description
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).
Outcomes
Primary Outcome Measures
Pain relief
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
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.
Full Information
NCT ID
NCT01636999
First Posted
July 6, 2012
Last Updated
October 1, 2020
Sponsor
West Penn Allegheny Health System
1. Study Identification
Unique Protocol Identification Number
NCT01636999
Brief Title
Comparing Sedara to Butorphanol in Early Labor
Official Title
Comparing Pain Relief in Early Labor: Nitrous Oxide Versus Butorphonol Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Penn Allegheny Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Sedara, Nitrous Oxide, Butorphanol, Visual Analog Scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butorphanol
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
50% Nitrous Oxide/50% Oxygen
Other Intervention Name(s)
Sedara (FDA 510K Approval No. K101286)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Nausea, Sedation, Satisfaction
Description
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.
Time Frame
60 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Finegold, MD
Organizational Affiliation
Associate Residency Program Director
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Troianos, MD
Organizational Affiliation
Residency Program Director
Official's Role
Study Chair
Facility Information:
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
152064231
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21451402
Citation
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Results Reference
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Citation
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Citation
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PubMed Identifier
20677364
Citation
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PubMed Identifier
8598984
Citation
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Citation
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Comparing Sedara to Butorphanol in Early Labor
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