Association Between Body Size and Response to Hydromorphone in ED
2020年10月6日 更新者：Albert Einstein College of Medicine
Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain
Pain is the most common complaint for patients presenting to the emergency department (ED).
Inadequate pain relief is also a common problem in ED.
Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors.
The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.
研究概览
详细说明
Pain is the most common complaint for patients presenting to the emergency department (ED). Morphine and hydromorphone are the two most commonly administrated intravenous opioid analgesics. However, a large inter-individual variation in the response to morphine or hydromorphone has been observed and a significant number of patients do not have satisfactory pain relief after receiving commonly administered doses of these two medications. Current studies have focused on investigating optimal strategies of intravenous opioid use for moderate and severe pain in the ED.
Contrary to the commonly recommended total body weight (TBW) based dosing strategy, a recent publication did not demonstrate a linear relationship between TBW and clinical response to morphine.
The ultimate goal of the research is to identify optimal methods of dosing opioids to alleviate pain in ED patients. The objective of this study is to examine the association between two measures of body size/body composition and response to a standard dose of hydromorphone. The null hypothesis is that there is no association between the measures of body size/composition and response to 1 mg hydromorphone, and thus no difference between the associations. If a strong association exists between TBW or BMI and pain response, it will lend support for the importance of taking body size or composition into account when making decisions about hydromorphone dosing in the ED. It will lay the groundwork for future studies of analgesic dosing. This is of particular importance given the increasing prevalence of obesity in the US and other developed nations.
Specific Aims:
- To test the association between analgesic response to a standard dose of hydromorphone and total body weight in ED patients with acute pain requiring intravenous opioid analgesia.
- To test the association between analgesic response to a standard dose of hydromorphone and BMI.
- To compare the associations between analgesic response to a standard dose of hydromorphone and the two measures of body size/composition, BMI and TBW.
- To assess whether the associations between response to hydromorphone and these measures of body size/composition are confounded or modified by gender, age, ethnicity and certain genetic polymorphisms.
The results of the current study will suggest whether body size or composition play a role in the clinical response to hydromorphone and may lay the groundwork for further studies to determine whether dosing should be modified to take these characteristics into account either continuously, e.g. 0.015 mg/kg hydromorphone or categorically (increasing doses by category of BMI).
研究类型
介入性
注册 (实际的)
174
阶段
- 阶段2
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
-
-
New York
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Bronx、New York、美国、10461
- Jacobi Medical Center
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Bronx、New York、美国、10467
- North Central Bronx 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 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- English or Spanish speaking
- Age 18 - 65 years old
- Acute pain (less than 7 days in duration)
- Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician
Exclusion Criteria:
- Allergy to hydromorphone
- Systolic blood pressure < 90 mm Hg
- Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen
- Alcohol or other drug intoxication as judged by the attending physician
- Suspicion of drug seeking by ED physician
- Use of opioids within the past 24 hours
- Use of a monoamine oxidase inhibitor
- Concurrent use of benzodiazepines
- Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia)
- History of COPD, sleep apnea, renal failure, liver disease
- Pregnancy or breast feeding
- Prior entry of patient in the study
- Inability or unwillingness to provide informed consent
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Hydromorphone
Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Pain scale change, patients' satisfaction, requirements for additional pain medications, side effects and adverse events will be recorded at 15 and 30 minutes.
Patients' weight and height will be measured.
Age, gender, and race/ethnicity will also be recorded.
Blood draw for genetic study will be performed.
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a fixed dose (1 mg) of hydromorphone will be given to the study subjects
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 |
|---|---|---|
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Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
大体时间：30 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
|
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Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
大体时间：30 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
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30 minutes post-treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
大体时间：15 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
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15 minutes post-treatment
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Pain Treatment Satisfaction Levels as Assessed by Self-report
大体时间：30 minutes post-treatment
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Participant's satisfaction with their treatment were assessed by self-report.
After treatment, participants were asked "How satisfied are you with the result of your pain treatment today?" and they were told to pick their satisfaction level from "very dissatisfied," "dissatisfied," "uncertain," "satisfied," and "very satisfied."
Participants at each level is reported.
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30 minutes post-treatment
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Number of Participants With Oxygen Saturation Level < 92%
大体时间：30 minutes post-treatment
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Opioids can induce respiratory depression, which could lead to low oxygen saturation level.
Prolonged low oxygen saturation level < 92% could cause brain damage.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
|
30 minutes post-treatment
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Number of Participants With Nausea
大体时间：30 minutes post-treatment
|
Opioids can could induce nausea.
Number of participants with nausea is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
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30 minutes post-treatment
|
|
Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of gender on the correlation between Total Body Weight (TBW) and change in pain intensity.
Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
|
30 minutes post-treatment
|
|
Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of race/ethnicity on the correlation between total body weight (TBW) and change in pain intensity.
Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW).
The reported value represents the correlation coefficient.
|
30 minutes post-treatment
|
|
Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid receptor (OPRM1, A118G).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The median and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
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30 minutes post-treatment
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Effects of Age on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
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Age might affect the responses to the hydromorphone treatment.
The effects of age on the correlation between total body weight (TBW) and change in pain intensity.
The mean of age was compared in TBW tertile groups.
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30 minutes post-treatment
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Number of Participant With Systolic Blood Pressure < 90 mmHg
大体时间：30 minutes post-treatment
|
Opioids can induce low blood pressure.
Prolonged low systolic blood pressure < 90 mmHg can cause shock and multi-organ failure.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
|
30 minutes post-treatment
|
|
Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of gender on the correlation between body mass index (BMI) and change in pain intensity.
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
|
30 minutes post-treatment
|
|
Number of Participants With Vomit
大体时间：30 minutes post-treatment
|
Opioids can induce vomit.
Number of participants with vomit is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
|
30 minutes post-treatment
|
|
Number of Participants With Skin Itching
大体时间：30 minutes post-treatment
|
Opioids can induce skin itching.
Number of participants with skin itching is reported.
Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.
|
30 minutes post-treatment
|
|
Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
大体时间：15 minutes post-treatment
|
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment.
Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI).
The reported value represents the correlation coefficient.
|
15 minutes post-treatment
|
|
Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid transporter (ABCB1, C3435T).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
|
30 minutes post-treatment
|
|
Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving pain sensitivity (COMT, G1947A).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
|
30 minutes post-treatment
|
|
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
大体时间：30 minutes post-treatment
|
This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity.
Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid metabolism (UGT2B7, -G840A).
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain).
The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment.
The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.
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30 minutes post-treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Desired for More Analgesics
大体时间：30 minutes post-treatment
|
Some participants liked to receive additional analgesics after hydromorphone treatment.
Number of participants who desired for additional analgesics is reported.
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30 minutes post-treatment
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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：Adrienne Birnbaum, MD、Jacobi Medical Center, Albert Einstein College of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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10月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2012年8月23日
首先提交符合 QC 标准的
2012年8月28日
首次发布 (估计)
2012年8月30日
研究记录更新
最后更新发布 (实际的)
2020年10月8日
上次提交的符合 QC 标准的更新
2020年10月6日
最后验证
2020年10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.