Association Between Body Size and Response to Hydromorphone in ED

Pain Clinical Trial

Official title:

Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675778
• Other study ID #: 2011-445
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• Hydromorphone
a fixed dose (1 mg) of hydromorphone will be given to the study subjects

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	North Central Bronx Hospital	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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