A Randomized, Controlled Trial of IV Acetaminophen Versus IV Morphine to Manage Pain in Pregnancy: Can Opioid Use be Reduced in Pregnant Women?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
研究概览
简要总结
Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal adverse effects compared to opioids.
Design: This is a comparative effective trial that is a randomized, controlled trial of IV acetaminophen vs. IV morphine in pregnant women.
Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV acetaminophen or IV morphine. The IV acetaminophen group will get up to four standard doses of IV acetaminophen during their stay at the hospital. The second group will get up to six standard doses of morphine. Subjects will complete a pain scale after medication administration and will be asked about any side effects.
详细描述
Rationale for this clinical trial The goal of analgesia in pregnancy is to reduce pain while minimizing both maternal and fetal adverse effects. Current opioids used in pregnancy provide minimal pain relief and are associated with adverse effects. IV acetaminophen has been shown to significantly improve pain control following cesarean section and in the first stage of labor. Moreover, IV acetaminophen reduces the need and consumption of opioids following surgery. If IV acetaminophen can be as effective in controlling pain associated with maternal medical conditions and uterine contractions with labor, then the use of parenteral opioids in pregnant women and its exposure to the fetus could be reduced. This could provide new opportunities in the medical management of pain in pregnancy. Thus we propose a comparative effectiveness trial of IV acetaminophen compared to IV morphine.
Hypothesis:
We hypothesize that IV acetaminophen is as effective as IV morphine in reducing pain in pregnant women. In doing so, IV acetaminophen can reduce the amount of narcotics needed in women with pain.
Objectives:
To determine if IV acetaminophen can:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IV Acetaminophen
IV acetaminophen for pain control
干预措施: IV Acetaminophen (Drug)
IV morphine
IV morphine for pain control
干预措施: IV Morphine (Drug)
结局指标
主要结局
Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
时间窗: baseline, 120 minutes after administration
The visual analogue scale (VAS) ranges from 0mm to 140mm. The subject will be asked to mark with a pen on the scale to rate their pain. Negative differences in scores indicated a pain score worse than baseline and positive differences indicated an improved pain score from baseline.
次要结局
- Pain Relief Based on a 5 Point Verbal Scale(24 hrs)
- Number of Participants Who Received Rescue Medications(24 hours after administration)
- Quantity of Rescue Medication Over 24 Hours(24 hours after administration)
- Total Amount of Study Drug Administered(24 hours after administration)
- Patient's Global Satisfaction at 24 Hours(24hrs)
- Number of Participants With Maternal Side Effects(1 hour after administration)
- Number of Participants With Fetal Heart Rate Changes(1 hour after administration)
研究者
Jerrie Refuerzo
Associate Professor
The University of Texas Health Science Center, Houston