Pain
Conditions
Keywords
hydromorphone, acute pain, emergency department
Brief summary
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.
Detailed description
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).
Interventions
DRUGHydromorphone
a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* English or Spanish speaking * Age 18 - 65 years old * Acute pain (less than 7 days in duration) * Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician
Exclusion criteria
* Allergy to hydromorphone * Systolic blood pressure \< 90 mm Hg * Room air oxygen saturation by pulse oximetry \< 95% at baseline without supplemental oxygen * Alcohol or other drug intoxication as judged by the attending physician * Suspicion of drug seeking by ED physician * Use of opioids within the past 24 hours * Use of a monoamine oxidase inhibitor * Concurrent use of benzodiazepines * Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia) * History of COPD, sleep apnea, renal failure, liver disease * Pregnancy or breast feeding * Prior entry of patient in the study * Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment | 30 minutes post-treatment | Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. |
| Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment | 30 minutes post-treatment | Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Treatment Satisfaction Levels as Assessed by Self-report | 30 minutes post-treatment | 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. |
| Number of Participants With Oxygen Saturation Level < 92% | 30 minutes post-treatment | 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. |
| Number of Participants With Nausea | 30 minutes post-treatment | Opioids can could induce nausea. Number of participants with nausea is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. |
| Effect of Gender on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of gender on the correlation between Total Body Weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. |
| Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of race/ethnicity on the correlation between total body weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. |
| Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid receptor (OPRM1, A118G). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The median and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. |
| Effects of Age on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | 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. |
| Effect of Gender on the Correlation Between BMI and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of gender on the correlation between body mass index (BMI) and change in pain intensity. Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. |
| Number of Participants With Vomit | 30 minutes post-treatment | Opioids can induce vomit. Number of participants with vomit is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. |
| Number of Participants With Skin Itching | 30 minutes post-treatment | Opioids can induce skin itching. Number of participants with skin itching is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. |
| Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment | 15 minutes post-treatment | Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. |
| Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid transporter (ABCB1, C3435T). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. |
| Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving pain sensitivity (COMT, G1947A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. |
| Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity | 30 minutes post-treatment | This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid metabolism (UGT2B7, -G840A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. |
| Number of Participant With Systolic Blood Pressure < 90 mmHg | 30 minutes post-treatment | Opioids can induce low blood pressure. Prolonged low systolic blood pressure \< 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. |
| Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment | 15 minutes post-treatment | Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Desired for More Analgesics | 30 minutes post-treatment | Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported. |
Countries
United States
Participant flow
Recruitment details
Participants were patients with acute pain recruited from the Emergency Department at Jacobi Medical Center
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone. | 163 |
| Total | 163 |
Baseline characteristics
| Characteristic | Hydromorphone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 163 Participants |
| Age, Continuous | 39 year STANDARD_DEVIATION 12 |
| Cause of pain Injury | 15 Participants |
| Cause of pain Noninjury | 148 Participants |
| Pain duration | 1 days |
| Race/Ethnicity, Customized Asian/Pacific Islander | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 40 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 93 Participants |
| Race/Ethnicity, Customized Others | 7 Participants |
| Race/Ethnicity, Customized White | 15 Participants |
| Region of Enrollment United States | 163 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 174 |
| other Total, other adverse events | 52 / 174 |
| serious Total, serious adverse events | 1 / 174 |
Outcome results
Primary
Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.
Time frame: 30 minutes post-treatment
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydromorphone | Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment | -0.04 correlation coefficient |
Primary
Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.
Time frame: 30 minutes post-treatment
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydromorphone | Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment | -0.03 correlation coefficient |
Secondary
Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.
Time frame: 15 minutes post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydromorphone | Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment | -0.05 correlation coefficient |
Secondary
Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.
Time frame: 15 minutes post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydromorphone | Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment | -0.06 correlation coefficient |
Secondary
Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone | Effect of Gender on the Correlation Between BMI and Change in Pain Intensity | Female | 0.0017 correlation coefficient |
| Hydromorphone | Effect of Gender on the Correlation Between BMI and Change in Pain Intensity | Male | 0.1887 correlation coefficient |
Secondary
Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone | Effect of Gender on the Correlation Between TBW and Change in Pain Intensity | Female | 0.06 correlation coefficient |
| Hydromorphone | Effect of Gender on the Correlation Between TBW and Change in Pain Intensity | Male | 0.11 correlation coefficient |
Secondary
Effects of Age on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone | Effects of Age on the Correlation Between TBW and Change in Pain Intensity | low TBW tertile | 39.5 years | Standard Deviation 11 |
| Hydromorphone | Effects of Age on the Correlation Between TBW and Change in Pain Intensity | medium TBW tertile | 42.1 years | Standard Deviation 11 |
| Hydromorphone | Effects of Age on the Correlation Between TBW and Change in Pain Intensity | high TBW tertile | 39.3 years | Standard Deviation 14.1 |
Secondary
Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
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%).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydromorphone | Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity | Hispanic | -0.03 correlation coefficient |
| Hydromorphone | Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity | African American | 0.08 correlation coefficient |
Secondary
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity | AA | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity | AG | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity | GG | 6.0 score on a scale |
Secondary
Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity | GG | 6.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity | AA | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity | AG | 7.0 score on a scale |
Secondary
Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity | CC | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity | CT | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity | TT | 6.0 score on a scale |
Secondary
Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity | AA | 5.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity | AG | 6.0 score on a scale |
| Hydromorphone | Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity | GG | 5.0 score on a scale |
Secondary
Number of Participants With Nausea
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants With Nausea | 33 Participants |
Secondary
Number of Participants With Oxygen Saturation Level < 92%
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants With Oxygen Saturation Level < 92% | 1 Participants |
Secondary
Number of Participants With Skin Itching
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants With Skin Itching | 15 Participants |
Secondary
Number of Participants With Vomit
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants With Vomit | 4 Participants |
Secondary
Number of Participant With Systolic Blood Pressure < 90 mmHg
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participant With Systolic Blood Pressure < 90 mmHg | 0 Participants |
Secondary
Pain Treatment Satisfaction Levels as Assessed by Self-report
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.
Time frame: 30 minutes post-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Very dissatisfied | 2 Participants |
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Dissatisfied | 8 Participants |
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Uncertain | 26 Participants |
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Satisfied | 68 Participants |
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Very satisfied | 57 Participants |
| Hydromorphone | Pain Treatment Satisfaction Levels as Assessed by Self-report | Missing | 2 Participants |
Other Pre-specified
Number of Participants Who Desired for More Analgesics
Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.
Time frame: 30 minutes post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Participants Who Desired for More Analgesics | 37 Participants |