<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675778</url>
  </required_header>
  <id_info>
    <org_study_id>2011-445</org_study_id>
    <nct_id>NCT01675778</nct_id>
    <nct_alias>NCT03789500</nct_alias>
  </id_info>
  <brief_title>Association Between Body Size and Response to Hydromorphone in ED</brief_title>
  <official_title>Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain is the most common complaint for patients presenting to the emergency department (ED).&#xD;
      Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and&#xD;
      responses to intravenous opioids vary widely and are influenced by multiple factors. The&#xD;
      objective of the current study is to examine the association between total body weight, BMI&#xD;
      (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is the most common complaint for patients presenting to the emergency department (ED).&#xD;
      Morphine and hydromorphone are the two most commonly administrated intravenous opioid&#xD;
      analgesics. However, a large inter-individual variation in the response to morphine or&#xD;
      hydromorphone has been observed and a significant number of patients do not have satisfactory&#xD;
      pain relief after receiving commonly administered doses of these two medications. Current&#xD;
      studies have focused on investigating optimal strategies of intravenous opioid use for&#xD;
      moderate and severe pain in the ED.&#xD;
&#xD;
      Contrary to the commonly recommended total body weight (TBW) based dosing strategy, a recent&#xD;
      publication did not demonstrate a linear relationship between TBW and clinical response to&#xD;
      morphine.&#xD;
&#xD;
      The ultimate goal of the research is to identify optimal methods of dosing opioids to&#xD;
      alleviate pain in ED patients. The objective of this study is to examine the association&#xD;
      between two measures of body size/body composition and response to a standard dose of&#xD;
      hydromorphone. The null hypothesis is that there is no association between the measures of&#xD;
      body size/composition and response to 1 mg hydromorphone, and thus no difference between the&#xD;
      associations. If a strong association exists between TBW or BMI and pain response, it will&#xD;
      lend support for the importance of taking body size or composition into account when making&#xD;
      decisions about hydromorphone dosing in the ED. It will lay the groundwork for future studies&#xD;
      of analgesic dosing. This is of particular importance given the increasing prevalence of&#xD;
      obesity in the US and other developed nations.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
        1. To test the association between analgesic response to a standard dose of hydromorphone&#xD;
           and total body weight in ED patients with acute pain requiring intravenous opioid&#xD;
           analgesia.&#xD;
&#xD;
        2. To test the association between analgesic response to a standard dose of hydromorphone&#xD;
           and BMI.&#xD;
&#xD;
        3. To compare the associations between analgesic response to a standard dose of&#xD;
           hydromorphone and the two measures of body size/composition, BMI and TBW.&#xD;
&#xD;
        4. To assess whether the associations between response to hydromorphone and these measures&#xD;
           of body size/composition are confounded or modified by gender, age, ethnicity and&#xD;
           certain genetic polymorphisms.&#xD;
&#xD;
      The results of the current study will suggest whether body size or composition play a role in&#xD;
      the clinical response to hydromorphone and may lay the groundwork for further studies to&#xD;
      determine whether dosing should be modified to take these characteristics into account either&#xD;
      continuously, e.g. 0.015 mg/kg hydromorphone or categorically (increasing doses by category&#xD;
      of BMI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment</measure>
    <time_frame>15 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Treatment Satisfaction Levels as Assessed by Self-report</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>Participant's satisfaction with their treatment were assessed by self-report. After treatment, participants were asked &quot;How satisfied are you with the result of your pain treatment today?&quot; and they were told to pick their satisfaction level from &quot;very dissatisfied,&quot; &quot;dissatisfied,&quot; &quot;uncertain,&quot; &quot;satisfied,&quot; and &quot;very satisfied.&quot; Participants at each level is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Oxygen Saturation Level &lt; 92%</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>Opioids can induce respiratory depression, which could lead to low oxygen saturation level. Prolonged low oxygen saturation level &lt; 92% could cause brain damage. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Nausea</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Gender on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Age on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participant With Systolic Blood Pressure &lt; 90 mmHg</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>Opioids can induce low blood pressure. Prolonged low systolic blood pressure &lt; 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Gender on the Correlation Between BMI and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vomit</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Skin Itching</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment</measure>
    <time_frame>15 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants Who Desired for More Analgesics</measure>
    <time_frame>30 minutes post-treatment</time_frame>
    <description>Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Hydromorphone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
    <arm_group_label>Hydromorphone</arm_group_label>
    <other_name>dilaudid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Age 18 - 65 years old&#xD;
&#xD;
          -  Acute pain (less than 7 days in duration)&#xD;
&#xD;
          -  Pain with sufficient severity to warrant use of intravenous opioids in the judgment of&#xD;
             ED attending physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to hydromorphone&#xD;
&#xD;
          -  Systolic blood pressure &lt; 90 mm Hg&#xD;
&#xD;
          -  Room air oxygen saturation by pulse oximetry &lt; 95% at baseline without supplemental&#xD;
             oxygen&#xD;
&#xD;
          -  Alcohol or other drug intoxication as judged by the attending physician&#xD;
&#xD;
          -  Suspicion of drug seeking by ED physician&#xD;
&#xD;
          -  Use of opioids within the past 24 hours&#xD;
&#xD;
          -  Use of a monoamine oxidase inhibitor&#xD;
&#xD;
          -  Concurrent use of benzodiazepines&#xD;
&#xD;
          -  Presence of a chronic pain syndrome (such as sickle cell disease, peripheral&#xD;
             neuropathy, diabetic neuropathy, or fibromyalgia)&#xD;
&#xD;
          -  History of COPD, sleep apnea, renal failure, liver disease&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Prior entry of patient in the study&#xD;
&#xD;
          -  Inability or unwillingness to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrienne Birnbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jacobi Medical Center, Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jacobi Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Central Bronx Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>May 9, 2018</results_first_submitted>
  <results_first_submitted_qc>October 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hydromorphone</keyword>
  <keyword>acute pain</keyword>
  <keyword>emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydromorphone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were patients with acute pain recruited from the Emergency Department at Jacobi Medical Center</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Hydromorphone</title>
          <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.</population>
      <group_list>
        <group group_id="B1">
          <title>Hydromorphone</title>
          <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="163"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>age</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>age</description>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>gender</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cause of pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Noninjury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain duration</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <population>174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.</population>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment</title>
          <description>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.</description>
          <population>174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" lower_limit="-0.18" upper_limit="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment</title>
        <description>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.</description>
        <time_frame>15 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment</title>
          <description>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.</description>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" lower_limit="-0.21" upper_limit="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Treatment Satisfaction Levels as Assessed by Self-report</title>
        <description>Participant's satisfaction with their treatment were assessed by self-report. After treatment, participants were asked &quot;How satisfied are you with the result of your pain treatment today?&quot; and they were told to pick their satisfaction level from &quot;very dissatisfied,&quot; &quot;dissatisfied,&quot; &quot;uncertain,&quot; &quot;satisfied,&quot; and &quot;very satisfied.&quot; Participants at each level is reported.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Treatment Satisfaction Levels as Assessed by Self-report</title>
          <description>Participant's satisfaction with their treatment were assessed by self-report. After treatment, participants were asked &quot;How satisfied are you with the result of your pain treatment today?&quot; and they were told to pick their satisfaction level from &quot;very dissatisfied,&quot; &quot;dissatisfied,&quot; &quot;uncertain,&quot; &quot;satisfied,&quot; and &quot;very satisfied.&quot; Participants at each level is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uncertain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Oxygen Saturation Level &lt; 92%</title>
        <description>Opioids can induce respiratory depression, which could lead to low oxygen saturation level. Prolonged low oxygen saturation level &lt; 92% could cause brain damage. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Oxygen Saturation Level &lt; 92%</title>
          <description>Opioids can induce respiratory depression, which could lead to low oxygen saturation level. Prolonged low oxygen saturation level &lt; 92% could cause brain damage. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Nausea</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Nausea</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Gender on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Gender on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="-0.25" upper_limit="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="-0.15" upper_limit="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <population>Only Hispanic and African American were analyzed, since these two populations were most common in our study participants (Hispanic 57.1%; African American 24.5%).</population>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <population>Only Hispanic and African American were analyzed, since these two populations were most common in our study participants (Hispanic 57.1%; African American 24.5%).</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" lower_limit="-0.17" upper_limit="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" lower_limit="-0.24" upper_limit="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="4" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Age on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Age on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>low TBW tertile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>medium TBW tertile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high TBW tertile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Who Desired for More Analgesics</title>
        <description>Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Desired for More Analgesics</title>
          <description>Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <population>174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.</population>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment</title>
          <description>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.</description>
          <population>174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" lower_limit="-0.16" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participant With Systolic Blood Pressure &lt; 90 mmHg</title>
        <description>Opioids can induce low blood pressure. Prolonged low systolic blood pressure &lt; 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With Systolic Blood Pressure &lt; 90 mmHg</title>
          <description>Opioids can induce low blood pressure. Prolonged low systolic blood pressure &lt; 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Gender on the Correlation Between BMI and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Gender on the Correlation Between BMI and Change in Pain Intensity</title>
          <description>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.</description>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0017" lower_limit="-0.193" upper_limit="0.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1887" lower_limit="-0.064" upper_limit="0.418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vomit</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vomit</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Skin Itching</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Skin Itching</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment</title>
        <description>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.</description>
        <time_frame>15 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment</title>
          <description>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.</description>
          <units>correlation coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" lower_limit="-0.21" upper_limit="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity</title>
        <description>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.</description>
        <time_frame>30 minutes post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hydromorphone</title>
            <description>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.&#xD;
Hydromorphone: a fixed dose (1 mg) of hydromorphone will be given to the study subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity</title>
          <description>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.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored and recorded till 30 minutes after hydromorphone administration while participants were at the ED.</time_frame>
      <desc>Oxygen saturation was measured by pule oximetry. Blood pressure was measured by blood pressure monitor. Nausea, vomit, and itching were recorded by direct observation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Hydromorphone</title>
          <description>Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oxygen saturation level &lt; 92%</sub_title>
                <description>Hydromorphone could cause respiratory depression, which could lead to low oxygen saturation level.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Hydromorphone could cause nausea.</description>
                <counts group_id="E1" events="33" subjects_affected="33" subjects_at_risk="174"/>
              </event>
              <event>
                <sub_title>Vomit</sub_title>
                <description>Hydromorphone could cause vomit.</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching</sub_title>
                <description>Hydromorphone could cause skin itching.</description>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="174"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Shujun Xia</name_or_title>
      <organization>Jacobi Medical Center</organization>
      <phone>718-918-5800</phone>
      <email>shujun.xia@nbhn.net</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675778
org study id: 2011-445
nct id: NCT01675778
nct alias: NCT03789500
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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:

        1. 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.

        2. To test the association between analgesic response to a standard dose of hydromorphone
           and BMI.

        3. To compare the associations between analgesic response to a standard dose of
           hydromorphone and the two measures of body size/composition, BMI and TBW.

        4. 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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
time frame: 30 minutes post-treatment
description: 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.
measure: Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
time frame: 30 minutes post-treatment
description: 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.
measure: Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
time frame: 15 minutes post-treatment
description: 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.
measure: Pain Treatment Satisfaction Levels as Assessed by Self-report
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participants With Oxygen Saturation Level < 92%
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participants With Nausea
time frame: 30 minutes post-treatment
description: 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.
measure: Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Effects of Age on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participant With Systolic Blood Pressure < 90 mmHg
time frame: 30 minutes post-treatment
description: 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.
measure: Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participants With Vomit
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participants With Skin Itching
time frame: 30 minutes post-treatment
description: 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.
measure: Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
time frame: 15 minutes post-treatment
description: 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.
measure: Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
time frame: 30 minutes post-treatment
description: 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.
measure: Number of Participants Who Desired for More Analgesics
time frame: 30 minutes post-treatment
description: Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.
arm group label: Hydromorphone
arm group type: Other
description: 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.
intervention type: Drug
intervention name: Hydromorphone
description: a fixed dose (1 mg) of hydromorphone will be given to the study subjects
arm group label: Hydromorphone
other name: dilaudid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Adrienne Birnbaum, MD
role: Principal Investigator
affiliation: Jacobi Medical Center, Albert Einstein College of Medicine
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Pain
mesh term: Hydromorphone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 