Safety and Efficacy Study of Hydromorphone and Morphine
Information source: Chang, Andrew, M.D.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Morphine and Hydromorphone (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Chang, Andrew, M.D.
Official(s) and/or principal investigator(s):
Andrew K Chang, MD, Principal Investigator, Affiliation: Montefiore Medical Center
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
Official title: Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: Secondary outcomes included pain score comparisons at 5 minutes and 120 minutes, additional pain medications administered after initial medication, and comparison of adverse events
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).
Minimum age: 21 Years.
Maximum age: 65 Years.
- 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.
- 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)
Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467, United States
Starting date: October 2004
Ending date: January 2005
Last updated: September 12, 2005