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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

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE October 2004
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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).
  • 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).
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Secondary outcomes included pain score comparisons at 5 minutes and 120 minutes, additional pain medications administered after initial medication, and comparison of adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Hydromorphone and Morphine
Official Title  ICMJE Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Morphine
    0.1 mg/kg IV morphine
  • Drug: Hydromorphone
    0.015 mg/kg IV hydromorphone
    Other Name: Dilaudid
Study Arms  ICMJE
  • Active Comparator: Morphine

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

    intervention: 0.1 mg/kg IV morphine

    Intervention: Drug: Morphine
  • Experimental: Hydromorphone

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

    intervention: 0.015 mg/kg IV hydromorphone

    Intervention: Drug: Hydromorphone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2005)
198
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195910
Other Study ID Numbers  ICMJE MMC-04-08-225
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Chang, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew K Chang, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP