跳至主要内容
临床试验/NCT01636999
NCT01636999撤回不适用

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

West Penn Allegheny Health System1 个研究点 分布在 1 个国家开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Pain relief

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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).

干预措施: 50% Nitrous Oxide/50% Oxygen (Drug)

结局指标

主要结局

Pain relief

时间窗: 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.

次要结局

  • Nausea, Sedation, Satisfaction(60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Comparing Sedara to Butorphanol in Early Labor | 临床试验