Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
2016年9月8日 更新者：Mallinckrodt
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
研究概览
详细说明
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.
研究类型
介入性
注册 (实际的)
331
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35249
- University of Alabama (Anesthesiology)
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Sheffield、Alabama、美国、35660
- Helen Keller Hospital
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Arizona
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Phoenix、Arizona、美国、85032
- Precision Trials
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Phoenix、Arizona、美国、85023
- Arizona Research Center, Inc (JC Lincoln)
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Phoenix、Arizona、美国、85023
- Arizona Research Center, Inc. (Arrowhead)
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California
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Arcadia、California、美国、91007
- Arcadia Methodist Hospital
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Glendale、California、美国、91206
- Glendale Adventist Medical Center
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Pasadena、California、美国、91105
- Huntington Memorial Hospital
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San Clemente、California、美国、92672
- Accurate Clinical Trials, Inc.
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Florida
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Boynton Beach、Florida、美国、33414
- Visions Clinical Research
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Fort Pierce、Florida、美国、34950
- G and G Research, Inc.
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Holly Hill、Florida、美国、32117
- Century Clinical Research, Inc
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Inverness、Florida、美国、34452
- Nature Coast Clinical Research
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Miami、Florida、美国、33136
- University of Miami School of Medicine Dept. of Anesthesiology
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Vero Beach、Florida、美国、32960
- Treasure Coast Obstetrics and Gynecology
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Michigan
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Royal Oak、Michigan、美国、48073
- William Beaumont Hospital
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New Jersey
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Camden、New Jersey、美国、08103
- Cooper Anesthesia
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New Brunswick、New Jersey、美国、08901
- St. Peters University Hospital, Anesthesiology
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New York
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Albany、New York、美国、11208
- Albany Medical College Dept. of Anesthesiology
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Bronx、New York、美国、10461
- Jacobi Medical Center (Albert Einstein College of Medicine)
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New York、New York、美国、10021
- Weill Medical College
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Stony Brook、New York、美国、11794
- Stony Brook Anesthesiology Health Sciences Cente
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University Medical Center
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Pennsylvania
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Altoona、Pennsylvania、美国、16602
- Allegheny Pain Managment
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University Dept. of Anesthesiology
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Texas
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Houston、Texas、美国、77024
- Memorial Herman/Memorial City Hospital
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Houston、Texas、美国、77024
- Texas Woman's Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
- 18-75 years of age
- Body Mass Index (BMI) between 19-45
- American Society of Anesthesiologists (ASA) risk class of I, II, III
- Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
- Moderate to Severe pain at rest
Exclusion Criteria:
- Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
- Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
- Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
- Known history of alcohol or drug abuse or misuse
- Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
- Has significant medical disease(s), or conditions that may contraindicate participation in the study
- Has participated in another clinical trial within 30 days of surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：IV acetaminophen 1 g/100 mL solution
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Intravenous acetaminophen 1 g/100 mL
其他名称：
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安慰剂比较：IV Placebo 100 mL solution
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IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
大体时间：Baseline (just prior to the first dose) through 24 hours
|
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours.
SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment.
Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable".
The range of measurement is 0-2400 mm for 24 hours.
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Baseline (just prior to the first dose) through 24 hours
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Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
大体时间：Baseline (just prior to the first dose) through 48 hours
|
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours.
SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment.
Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable".
The range of measurement is 0-4800 mm for 48 hours.
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Baseline (just prior to the first dose) through 48 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
大体时间：First dose through 7 day follow up
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Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)
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First dose through 7 day follow up
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Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
大体时间：32 days following first dose of study medication.
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Number of subjects who reported SAEs during the study. A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that: Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event |
32 days following first dose of study medication.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年11月1日
初级完成 (实际的)
2007年9月1日
研究完成 (实际的)
2007年9月1日
研究注册日期
首次提交
2006年11月14日
首先提交符合 QC 标准的
2006年11月14日
首次发布 (估计)
2006年11月15日
研究记录更新
最后更新发布 (估计)
2016年10月21日
上次提交的符合 QC 标准的更新
2016年9月8日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.