Pain Clinical Trial
Official title:
Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain
NCT number | NCT01675778 |
Other study ID # | 2011-445 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | December 2012 |
Verified date | October 2020 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | December 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
United States | North Central Bronx Hospital | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 15 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 15 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment | |
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. | 30 minutes post-treatment |
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