Comparing Sedara to Butorphanol in Early Labor

Sponsor

West Penn Allegheny Health System (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01636999

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: 50% Nitrous Oxide/50% Oxygen	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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 Names: Sedara (FDA 510K Approval No. K101286)

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 Names:

Sedara (FDA 510K Approval No. K101286)

Outcome Measures

Primary Outcome Measures

Pain relief [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

Nausea, Sedation, Satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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