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临床试验/NCT02181387
NCT02181387终止4 期

Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年9月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
33
试验地点
1
主要终点
Neuraxial Analgesic Drug Consumption Per Hour

研究概览

简要总结

The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.

详细描述

Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • >/= 18 years of age not allergic to study medications

排除标准

  • pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects

研究组 & 干预措施

acetaminophen

Active Comparator

1000 mg every 6 hours during labor up to maximum 3 doses

干预措施: Acetaminophen (Drug)

placebo

Placebo Comparator

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses

干预措施: Placebo (Drug)

结局指标

主要结局

Neuraxial Analgesic Drug Consumption Per Hour

时间窗: up to 24 hours

subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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