Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
时间窗: 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.
Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
时间窗: 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.
次要结局
- Number of Participants With Oxygen Saturation Level < 92%(30 minutes post-treatment)
- Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Number of Participant With Systolic Blood Pressure < 90 mmHg(30 minutes post-treatment)
- Effect of Gender on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Pain Treatment Satisfaction Levels as Assessed by Self-report(30 minutes post-treatment)
- Number of Participants With Nausea(30 minutes post-treatment)
- Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Number of Participants With Vomit(30 minutes post-treatment)
- Number of Participants With Skin Itching(30 minutes post-treatment)
- Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment(15 minutes post-treatment)
- Effects of Age on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment(15 minutes post-treatment)
- Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Effect of Gender on the Correlation Between BMI and Change in Pain Intensity(30 minutes post-treatment)
- Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)
- Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity(30 minutes post-treatment)