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Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00305058
First received: March 17, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

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

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

Estimated Enrollment: 178
Study Start Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305058

Contacts
Contact: Andrew K Chang, MD 718-920-7464 achang3@yahoo.com

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Andrew K Chang, MD    718-920-7464    achang3@yahoo.com   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Andrew K Chang, MD Montefiore Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00305058     History of Changes
Other Study ID Numbers: MMC 04-08-225E
Study First Received: March 17, 2006
Last Updated: March 17, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Elderly
Hydromorphone
Morphine
Pain
Acute
Emergency Department

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Hydromorphone
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014