Comparing Sedara to Butorphanol in Early Labor
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | September 2014 |
| Contact: | Helene Finegold, MD |
| Email: | HFinegol@wpahs.org |
| Phone: | 412-578-5323 |
Comparing Pain Relief in Early Labor: Nitrous Oxide Versus Butorphonol Study
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.
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.
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
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