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Safety and Efficacy Study of Hydromorphone and Morphine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Chang, Andrew, M.D..   Recruitment status was  Active, not recruiting

First Received on September 12, 2005.   No Changes Posted
Sponsor: Chang, Andrew, M.D.
Information provided by: Chang, Andrew, M.D.
ClinicalTrials.gov Identifier: NCT00195910
  Purpose

To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the ED with acute severe pain.


Condition Intervention Phase
Pain
Drug: Morphine and Hydromorphone
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chang, Andrew, M.D.:

Primary Outcome Measures:
  • The primary outcome of this study was the between-group difference in change of NRS pain scores from baseline to 30 minutes after medications were infused.

Secondary Outcome Measures:
  • Secondary outcomes included pain score comparisons at 5 minutes and 120 minutes, additional pain medications administered after initial medication, and comparison of adverse events

Estimated Enrollment: 198
Study Start Date: October 2004
Estimated Study Completion Date: January 2005
Detailed Description:

There is widespread agreement that pain is under-treated in the ED (18). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved (19,20). Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients’ acute pain (21,22). In spite of this, we have observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, we observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, we reasoned that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, we reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED (18).

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults between the ages of 21 and 65 who presented to the ED with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ED attending to warrant use of IV opioids.

Exclusion Criteria:

  • previous allergy to morphine or hydromorphone, systolic blood pressure less than 90mmHg, alcohol intoxication as judged by the attending physician, use of other opioids within the past 7 days, use of an MAO-inhibitor, and patients with chronic pain syndromes (such as sickle cell disease or fibromyalgia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195910

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Chang, Andrew, M.D.
Investigators
Principal Investigator: Andrew K Chang, MD Montefiore Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195910     History of Changes
Other Study ID Numbers: MMC-04-08-225
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Chang, Andrew, M.D.:
Acute
Pain
Emergency Department
Morphine
Hydromorphone
Dilaudid

Additional relevant MeSH terms:
Hydromorphone
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012