Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Age Range:65 - Any
Start Date:July 2005
End Date:March 2007

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A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain

The purpose of this research study is to determine which opiate pain medication (morphine or
hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients
presenting to the emergency department.

Pain is cited as the most frequent reason for visit to emergency departments (EDs) . 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. 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".

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, delay early diagnosis, treatment, and contribute
to risks of tolerance and dependence in vulnerable patients.

The elderly represent a group of patients who may experience pain differently from the
non-elderly patient. This growing population has been significantly underrepresented in
pain-related studies. Some studies have shown that the elderly are at risk for
"oligoanalgesia" and receive inadequate doses of pain medication.

Morphine has long been considered the gold standard in pain control. Hydromorphone is another
powerful opiate 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. Of these 32 studies, only 9 involved intravenous
forms of hydromorphone. Of these 8 studies, 5 involved patient controlled analgesia, and only
1 study compared intravenous (IV) hydromorphone to IV morphine. The Cochrane review concludes
that there are gaps in the understanding of the efficacy and potency of hydromorphone. Only 1
study of hydromorphone in the ED could be located and this compared IV hydromorphone versus
IV meperidine in patients with ureteral colic. Although this study showed hydromorphone was
superior at all time periods and had fewer side effects, the study used fixed doses of
hydromorphone (1mg) and meperidine (50mg).

It has been the clinical experience of some ED physicians that hydromorphone may be a better
opiate in patients presenting to the ED with acute pain. Hydromorphone is also the opiate
that is usually given if morphine does not adequately control a patient's pain in the ED.

Hydromorphone may also have other benefits, such as a faster onset since it is more
lipophilic than morphine and crosses the blood-brain barrier faster.

If it is shown that hydromorphone gives better pain relief to patients with comparable or
fewer side effects when compared with morphine, then we may be able to provide evidence to
suggest that hydromorphone should be the parenteral opiate of choice for adult ED patients
presenting with acute pain of moderate to severe intensity.

Inclusion Criteria:

1. Age greater than 65 years

2. Pain with onset within 7 days

3. ED attending physician's judgment that patient's pain warrants use of parenteral

4. 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 morphine or hydromorphone

4. Chronic pain syndrome

5. Alcohol intoxication

6. Systolic Blood Pressure <90 mm Hg

7. Use of monoamine oxidase (MAO) inhibitors in past 30 days

8. Elderly patients with a capnometry reading of greater than 46
We found this trial at
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Bronx, NY
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