Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305058
Recruitment Status : Unknown
Verified June 2005 by Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : March 21, 2006
Last Update Posted : March 21, 2006
Information provided by:
Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Morphine 0.05 mg/kg Intravenous Drug: Hydromorphone 0.0075 mg/kg intravenous Phase 4

Detailed Description:

Pain is cited as the most frequent reason for visit 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, 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 (Li 2001, Collins 1966, Walsh 1989, Woodrow 1972). 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 (Jones 1996).

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 (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 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 (Jasani, 1994). 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The between-group difference in before-after improvement in pain scores measured 30 minutes after medications are infused.

Secondary Outcome Measures :
  1. Pain score comparisons at 15 minutes and 120 minutes
  2. Total mg of additional pain medications required after initial medication
  3. Pain relief measurement
  4. Patient satisfaction measurement
  5. Comparison of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 opioids
  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. SBP <90 mm Hg
  7. Use of MAO inhibitors in past 30 days
  8. Elderly patients with a capnometry reading of greater than 46

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305058

Contact: Andrew K Chang, MD 718-920-7464

United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Andrew K Chang, MD    718-920-7464   
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Andrew K Chang, MD Montefiore Medical Center Identifier: NCT00305058     History of Changes
Other Study ID Numbers: MMC 04-08-225E
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: March 21, 2006
Last Verified: June 2005

Keywords provided by Montefiore Medical Center:
Emergency Department

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents