Safety and Efficacy Study of Hydromorphone and Morphine

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 pain.

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

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).

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Montefiore Medical Center, Bronx, New York 10467, United States

Starting date: October 2004
Ending date: January 2005
Last updated: September 12, 2005