Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- reduction of pain score on a visual analog scale (VAS) of 1-10
研究概览
简要总结
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.
Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.
This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 53 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •labor pain >3 on visual analog scale (VAS)
排除标准
- •cardiovascular disease
- •preeclampsia
- •diabetes mel-litus
- •thyroid disease
- •current (outpatient) opioid medication
- •recent and / or current use of cocaine
- •seizure disorder
- •psychiatric disease
- •body mass index >35
- •preterm labor (<37 weeks pregnant)
- •known allergies to any of the three study substances
研究组 & 干预措施
Terbutaline
Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
干预措施: Terbutaline (Drug)
Fentanyl
Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
干预措施: Fentanyl (Drug)
Placebo
0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
reduction of pain score on a visual analog scale (VAS) of 1-10
时间窗: 0-30 minutes
semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter
次要结局
- movement during epidural placement(0-30 minutes)
- position during epidural placement(0-30 minutes)
研究者
Kai Schoenhage
Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology
University of Arizona