Association Between Body Size and Response to Hydromorphone in ED
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): a fixed dose (1 mg) of hydromorphone will be given to the study subjects
Other intervention name(s): dilaudid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hydromorphone; acute pain; emergency department