Comparing Sedara to Butorphanol in Early Labor

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.

Conditions

• Labor Pain

Interventions

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.

Sponsors & Collaborators

• West Penn Allegheny Health System

  lead OTHER

Principal Investigators

• Helene Finegold, MD · Associate Residency Program Director

• Christopher Troianos, MD · Residency Program Director

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations