Comparing Sedara to Butorphanol in Early Labor

NCT01636999 | Withdrawn DMC

• 1 other identifier: 12-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Sedara; Nitrous Oxide; Butorphanol; Visual Analog Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes

Secondary Outcomes (1)

• Nausea, Sedation, Satisfaction

  60 minutes

Study Arms (1)

Butorphanol

EXPERIMENTAL

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

Interventions

50% Nitrous Oxide/50% Oxygen DRUG

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.

Also known as: Sedara (FDA 510K Approval No. K101286)

Butorphanol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Penn Allegheny Health System: lead

Study Sites (1)

West Penn Hospital

Pittsburgh, Pennsylvania, 152064231, United States

Location

Related Publications (12)

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  PMID: 21451402 BACKGROUND

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  PMID: 12011877 BACKGROUND

• Maslekar S, Gardiner A, Hughes M, Culbert B, Duthie GS. Randomized clinical trial of Entonox versus midazolam-fentanyl sedation for colonoscopy. Br J Surg. 2009 Apr;96(4):361-8. doi: 10.1002/bjs.6467.

  PMID: 19283736 BACKGROUND

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  PMID: 20677364 BACKGROUND

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  PMID: 8598984 BACKGROUND

• Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labour. Aust N Z J Obstet Gynaecol. 2003 Dec;43(6):463-8. doi: 10.1046/j.0004-8666.2003.00152.x.

  PMID: 14712952 BACKGROUND

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  PMID: 17158129 BACKGROUND

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  PMID: 19943458 BACKGROUND

• Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.

  PMID: 9835471 BACKGROUND

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  PMID: 12811707 BACKGROUND

• Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x.

  PMID: 14525749 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helene Finegold, MD

  Associate Residency Program Director

  PRINCIPAL INVESTIGATOR

• Christopher Troianos, MD

  Residency Program Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (1)