Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and speed of onset of 2mg intravenous
      hydromorphone (Dilaudid) in patients weighing at least 150 lbs presenting to the emergency
      department with acute severe pain
    

Detailed description: 
      Introduction and Background: Pain is cited as the most frequent reason for visits to
      emergency departments (EDs) (McCaig, 2001). It can be estimated from the National Hospital
      Ambulatory Medical Care Survey, an annual survey of a representative sample of visits to US
      EDs, that there are 17 million visits per year to US EDs for specific complaints of pain, 29
      million visits including "back symptoms" and "injuries not otherwise specified" as well as
      specific mentions of pain. However it is widely acknowledged that pain is seriously
      under-treated in the ED as well as in other health care settings (Ducharme, 1996; Selbst,
      1990; Wilson, 1989). The concern regarding under-treatment is reflected in new standards for
      pain management developed by the Joint Commission on Accreditation of Healthcare
      Organizations (JCAHO) requiring assessment of pain at triage in the ED and referring to pain
      measurement as the "fifth vital sign" (Philips, 2000).

      Proper pain management is a tremendous challenge to ED physicians as pain is not only a
      noxious experience but also a symptom of injury and disease that needs to be understood and
      appropriately treated. Further complicating pain management is the large interpersonal
      variability in pain perception and expression reflecting cultural, contextual, and individual
      differences between people. Reasons for under-treating pain include concern over side effects
      of opioids, perception of pain complaints as possible drug-seeking behavior, under-staffing,
      concern that analgesics will mask symptoms or delay early diagnosis and treatment, and
      contribute to risks of tolerance and dependence in vulnerable patients.

      Morphine has long been considered the gold standard in pain control. Hydromorphone is another
      powerful opioid that has been used extensively for the management of post-operative pain and
      morphine-resistant cancer-related pain. A recent Cochrane review on the use of hydromorphone
      found 32 studies that focused on acute pain (Quigley, 2003). Of these 32 studies, only 9
      involved intravenous forms of hydromorphone (Coda, 1997; Collins, 1996; Deutsch, 1968;
      Jasani, 1994; Liu, 1995; Mahler, 1975; Rapp, 1996; Searle, 1994; Urquhart, 1988). Of these 8
      studies, 5 involved patient controlled analgesia, and only 1 study compared IV hydromorphone
      to IV morphine (Mahler, 1975). The Cochrane review concludes that there are substantial gaps
      in the understanding of the efficacy and potency of hydromorphone.

      We have recently completed a study in non-elderly adult patients (IRB 04-08-225) that showed
      that weight-based IV hydromorphone provides better pain relief than weight-based IV morphine.
      This result was both statistically and clinically significant. We also demonstrated in this
      same study that IV hydromorphone has a faster onset and also provided statistically
      significant improvement in pain relief at 5 minutes as compared to IV morphine.

      Although weight-based dosing of medications is common in pediatrics, most emergency
      physicians use whole integer amounts of pain medications. IV hydromorphone is more potent
      than IV morphine, so the dosages given are much smaller. We therefore wish to give a standard
      2 mg dose of IV hydromorphone to all non-elderly adult patients weighing at least 150 lbs
      presenting to the ED with acute severe pain. We wish to examine the safety and speed of onset
      of hydromorphone using such a protocol.

      Our general thought is that to develop more evidence based practice, we need to generate more
      practice based evidence. This study attempts to do this as it is practiced based and very
      practical. We wish to take the drug as it comes (2mg Dilaudid in an ampule) and use all of
      it, thus alleviating the need to waste the excess opioid (and alleviating the need to find a
      second person to witness the wasting). We also wish to use a weight cutoff that everyone can
      remember (150 lbs). We believe that this protocol will provide greater pain relief and help
      address the issue of inadequate pain treatment, or "oligoanalgesia", that is prominent in the
      literature (Sobel 2002, Wilson, 1989, Goldfrank 2000).

      Finally, in our multiple studies of pain conducted in the ED, we have found a relatively high
      rate of refusal to receive pain medication. We think this may represent a component to the
      problem of oligoanalgesia that is widespread in the ED. We wish to investigate the reasons
      for patient refusal to receiving parental opioid medications (fear of addiction, side
      effects, etc).
    

Intervention name(s): 2 mg IV hydromorphone
Intervention type(s): Drug
Other intervention name(s): Dilaudid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Acute; Emergency Department; Severe; Hydromorphone; Dilaudid; Adult