Clinical trial NCT00195910: Safety and Efficacy Study of Hydromorphone and Morphine
Official title: Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Acute
Pain
Emergency Department
Morphine
Hydromorphone
Dilaudid
oligoanalgesia
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 198
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 Emergency Department (ED) with acute severe pain.

Detailed description: There is widespread agreement that pain is under-treated in the Emergency Department (ED). 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. 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. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been 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, it is reasonable 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, it is 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.

Eligibility 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 90 mmHg
* alcohol intoxication as judged by the attending physician
* use of other opioids within the past 7 days
* use of an Monoamine Oxidase (MAO) inhibitor
* chronic pain syndromes (such as sickle cell disease or fibromyalgia)

Primary outcomes:
measure: Change in Pain Intensity from baseline to 30 minutes after medications were infused.
timeFrame: baseline to 30 minutes after medication infused
Secondary outcomes:
measure: Pain intensity 5 minutes after medication is given
timeFrame: 5 minutes after medication is given
measure: Pain intensity 30 minutes after medication is given
timeFrame: 30 minutes after medication is given
measure: Pain intensity 2 hours after medication is given
timeFrame: 2 hours after medication is given
measure: Number of participants experiencing vomiting between baseline to 5 minutes after medication is given
timeFrame: baseline to 5 minutes after medication is given
measure: Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given
timeFrame: 6 minutes after medication is given to 30 minutes after medication is given
measure: Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given
timeFrame: 31 minutes after medication is given to 120 minutes after medication is given
measure: Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused
timeFrame: baseline to 5 minutes after medication was infused
measure: Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused
timeFrame: 6 minutes to 30 minutes after medication was infused
measure: Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused
timeFrame: 31 minutes to 120 minutes after medication was infused
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Andrew K Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: