Comparing Sedara to Butorphanol in Early Labor

Labor Pain Clinical Trial

Official title:

Comparing Pain Relief in Early Labor: Nitrous Oxide Versus Butorphonol Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01636999
• Other study ID #: 12-007
• Status: Withdrawn
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2020
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.

Locations

Country	Name	City	State
United States	West Penn Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rosen MA. Nitrous oxide for relief of labor pain: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S110-26. Review. — View Citation

Talebi H, Nourozi A, Jamilian M, Baharfar N, Eghtesadi-Araghi P. Entonox for labor pain: a randomized placebo controlled trial. Pak J Biol Sci. 2009 Sep 1;12(17):1217-21. — View Citation

Viscomi CM. Randomized trial of epidural versus intravenous analgesia during labor. Obstet Gynecol. 1996 Mar;87(3):480-2. — View Citation

Volmanen P, Akural E, Raudaskoski T, Ohtonen P, Alahuhta S. Comparison of remifentanil and nitrous oxide in labour analgesia. Acta Anaesthesiol Scand. 2005 Apr;49(4):453-8. — View Citation

Volmanen P, Palomäki O, Ahonen J. Alternatives to neuraxial analgesia for labor. Curr Opin Anaesthesiol. 2011 Jun;24(3):235-41. doi: 10.1097/ACO.0b013e328345ad18. Review. — View Citation

Yamamoto LG, Nomura JT, Sato RL, Ahern RM, Snow JL, Kuwaye TT. Minimum clinically significant VAS differences for simultaneous (paired) interval serial pain assessments. Am J Emerg Med. 2003 May;21(3):176-9. — View Citation

Yeo ST, Holdcroft A, Yentis SM, Stewart A, Bassett P. Analgesia with sevoflurane during labour: ii. Sevoflurane compared with Entonox for labour analgesia. Br J Anaesth. 2007 Jan;98(1):110-5. — View Citation

Young P, Emery NC, Reisin R. Epidural analgesia for labor and delivery. N Engl J Med. 2010 Jul 22;363(4):395. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	60 minutes