Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain
Intervention: Hydromorphone 2mg intravenous (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): Andrew K Chang, MD, Principal Investigator, Affiliation: Montefiore Medical Center
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
Clinical Details
Official title: Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary outcome of this study is the incidence of a serious adverse event by 120 minutes post infusion, which is defined as the use of naloxone as a reversal agent.
Secondary outcome: RR < 12 breaths per minute will be considered a less serious adverse eventThe RAs will note the presence of oxygen desaturation, defined as a pulse oximeter reading less than 90% or a decrease of 5% or more from baseline Systolic BP less than 90mg Hg will be counted as a less serious adverse event
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).
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age greater than 21 years
2. Age less than 65 years of age
3. Pain with onset within 7 days
4. ED attending physician's judgment that patient's pain warrants use of morphine
5. Normal mental status
Exclusion Criteria:
1. Prior use of methadone
2. Use of other opioids or tramadol within past seven days
3. Prior adverse reaction to hydromorphone.
4. Chronic pain syndrome
5. Alcohol intoxication
6. SBP <90 mm Hg
7. Use of MAO inhibitors in past 30 days
8. C02 measurement greater than 46
Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467, United States
Additional Information
Starting date: January 2006
Last updated: February 17, 2009
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