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Safety and Efficacy Study of Hydromorphone and Morphine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195910
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Morphine Drug: Hydromorphone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
Actual Study Start Date : October 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Morphine

single dose of intravenous (IV) morphine, 0.1 mg/kg

intervention: 0.1 mg/kg IV morphine

Drug: Morphine
0.1 mg/kg IV morphine

Experimental: Hydromorphone

single dose of intravenous (IV) hydromorphone, 0.015 mg/kg

intervention: 0.015 mg/kg IV hydromorphone

Drug: Hydromorphone
0.015 mg/kg IV hydromorphone
Other Name: Dilaudid




Primary Outcome Measures :
  1. Change in Pain Intensity from baseline to 30 minutes after medications were infused. [ Time Frame: baseline to 30 minutes after medication infused ]
    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable)


Secondary Outcome Measures :
  1. Pain intensity 5 minutes after medication is given [ Time Frame: 5 minutes after medication is given ]
    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  2. Pain intensity 30 minutes after medication is given [ Time Frame: 30 minutes after medication is given ]
    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  3. Pain intensity 2 hours after medication is given [ Time Frame: 2 hours after medication is given ]
    Pain intensity is measured by the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  4. Number of participants experiencing vomiting between baseline to 5 minutes after medication is given [ Time Frame: baseline to 5 minutes after medication is given ]
    Number of participants who experienced vomiting and required medication between baseline and 5 minutes after medication was infused

  5. Number of participants experiencing vomiting between 6 minutes after medication is given to 30 minutes after medication is given [ Time Frame: 6 minutes after medication is given to 30 minutes after medication is given ]
    Number of participants who experienced vomiting and required medication between 6 minutes after medication was infused and 30 minutes after medication was infused

  6. Number of participants experiencing vomiting between 31 minutes after medication is given to 120 minutes after medication is given [ Time Frame: 31 minutes after medication is given to 120 minutes after medication is given ]
    Number of participants who experienced vomiting and required medication between 31 minutes after medication was infused and 120 minutes after medication was infused

  7. Number of participants who received additional pain medication between baseline and 5 minutes after medication was infused [ Time Frame: baseline to 5 minutes after medication was infused ]
    Number of participants for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between baseline and 5 minutes after medication was infused

  8. Number of participants who received additional pain medication between 6 and 30 minutes after medication was infused [ Time Frame: 6 minutes to 30 minutes after medication was infused ]
    Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 6 and 30 minutes after the medication was infused

  9. Number of participants who received additional pain medication between 31 and 120 minutes after medication was infused [ Time Frame: 31 minutes to 120 minutes after medication was infused ]
    Number of patients for whom the administered pain medication was not sufficient, leading to the patient receiving additional pain medication between 31 and 120 minutes after medication was infused



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195910


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Andrew K Chang, MD Montefiore Medical Center
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Responsible Party: Andrew Chang, MD, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00195910    
Other Study ID Numbers: MMC-04-08-225
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew Chang, MD, Montefiore Medical Center:
Acute
Pain
Emergency Department
Morphine
Hydromorphone
Dilaudid
oligoanalgesia
Additional relevant MeSH terms:
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Morphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents