Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
2014年6月30日 更新者：Planned Parenthood League of Massachusetts
Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.
The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.
Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.
Secondary hypotheses include:
- Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
- Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
- Patients in the ketorolac group will be more satisfied with their pain control.
- Side effects will be similar between groups.
研究概览
研究类型
介入性
注册 (实际的)
94
阶段
- 不适用
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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Massachusetts
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Boston、Massachusetts、美国、02215
- Planned Parenthood League of Massachusetts
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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 及以上 (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:
- Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
- Gestational age less than or equal to 11+6, confirmed by ultrasound
- Eligible for suction curettage according to PPLM protocols
- Choice of local anesthesia
Exclusion Criteria:
- Choice of IV sedation for pain control
- Hypersensitivity to NSAIDs or lidocaine
- Contraindications to NSAIDs:
Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder
- NSAIDs taken < 8 hours prior to procedure
- Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
- Long-term narcotic use
- Unable or unwilling to complete required study procedures
- Previous participation in the study
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 |
|---|---|
|
实验性的：Ketorolac
Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet).
For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
|
For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure.
For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure
其他名称：
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|
有源比较器：Ibuprofen
Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo.
For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo
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For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure.
For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.
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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 |
|---|---|---|
|
Immediate Post-procedure Pain Score
大体时间：Immediately (within 1 minute) after suction and speculum removal
|
The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five).
This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).
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Immediately (within 1 minute) after suction and speculum removal
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Scores Immediately After Cervical Dilation
大体时间：Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
|
21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)
|
Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
|
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Pain Scores 15 Minutes Post-procedure
大体时间：Fifteen minutes after the procedure
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21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)
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Fifteen minutes after the procedure
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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。
调查人员
- 首席研究员：Principal Investigator, MD, MPH、Planned Parenthood League of Massachusetts
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
2011年6月1日
初级完成 (实际的)
2012年6月1日
研究完成 (实际的)
2012年6月1日
研究注册日期
首次提交
2011年5月19日
首先提交符合 QC 标准的
2012年5月8日
首次发布 (估计)
2012年5月10日
研究记录更新
最后更新发布 (估计)
2014年7月2日
上次提交的符合 QC 标准的更新
2014年6月30日
最后验证
2014年6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.