Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305058
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2006-03-17
Brief Title:
Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine which opiate pain medication morphine or hydromorphone Dilaudid is more effective in the treatment of acute pain in patients presenting to the emergency department
Detailed Description:
Pain is cited as the most frequent reason for visit to emergency departments EDs It can be estimated from the National Hospital Ambulatory Medical Care Survey an annual survey of a representative sample of visits to US EDs that there are 17 million visits per year to US EDs for specific complaints of pain 29 million visits including back symptoms and injuries not otherwise specified as well as specific mentions of pain However it is widely acknowledged that pain is seriously under-treated in the ED as well as in other health care settings The concern regarding under-treatment is reflected in new standards for pain management developed by the Joint Commission on Accreditation of Healthcare Organizations JCAHO requiring assessment of pain at triage in the ED and referring to pain measurement as the fifth vital sign
Proper pain management is a tremendous challenge to ED physicians as pain is not only a noxious experience but also a symptom of injury and disease that needs to be understood and appropriately treated Further complicating pain management is the large interpersonal variability in pain perception and expression reflecting cultural contextual and individual differences between people Reasons for under-treating pain include concern over side effects of opioids perception of pain complaints as possible drug-seeking behavior under-staffing concern that analgesics will mask symptoms delay early diagnosis treatment and contribute to risks of tolerance and dependence in vulnerable patients
The elderly represent a group of patients who may experience pain differently from the non-elderly patient This growing population has been significantly underrepresented in pain-related studies Some studies have shown that the elderly are at risk for oligoanalgesia and receive inadequate doses of pain medication
Morphine has long been considered the gold standard in pain control Hydromorphone is another powerful opiate that has been used extensively for the management of post-operative pain and morphine-resistant cancer-related pain A recent Cochrane review on the use of hydromorphone found 32 studies that focused on acute pain Of these 32 studies only 9 involved intravenous forms of hydromorphone Of these 8 studies 5 involved patient controlled analgesia and only 1 study compared intravenous IV hydromorphone to IV morphine The Cochrane review concludes that there are gaps in the understanding of the efficacy and potency of hydromorphone Only 1 study of hydromorphone in the ED could be located and this compared IV hydromorphone versus IV meperidine in patients with ureteral colic Although this study showed hydromorphone was superior at all time periods and had fewer side effects the study used fixed doses of hydromorphone 1mg and meperidine 50mg
It has been the clinical experience of some ED physicians that hydromorphone may be a better opiate in patients presenting to the ED with acute pain Hydromorphone is also the opiate that is usually given if morphine does not adequately control a patients pain in the ED
Hydromorphone may also have other benefits such as a faster onset since it is more lipophilic than morphine and crosses the blood-brain barrier faster
If it is shown that hydromorphone gives better pain relief to patients with comparable or fewer side effects when compared with morphine then we may be able to provide evidence to suggest that hydromorphone should be the parenteral opiate of choice for adult ED patients presenting with acute pain of moderate to severe intensity
Proper pain management is a tremendous challenge to ED physicians as pain is not only a noxious experience but also a symptom of injury and disease that needs to be understood and appropriately treated Further complicating pain management is the large interpersonal variability in pain perception and expression reflecting cultural contextual and individual differences between people Reasons for under-treating pain include concern over side effects of opioids perception of pain complaints as possible drug-seeking behavior under-staffing concern that analgesics will mask symptoms delay early diagnosis treatment and contribute to risks of tolerance and dependence in vulnerable patients
The elderly represent a group of patients who may experience pain differently from the non-elderly patient This growing population has been significantly underrepresented in pain-related studies Some studies have shown that the elderly are at risk for oligoanalgesia and receive inadequate doses of pain medication
Morphine has long been considered the gold standard in pain control Hydromorphone is another powerful opiate that has been used extensively for the management of post-operative pain and morphine-resistant cancer-related pain A recent Cochrane review on the use of hydromorphone found 32 studies that focused on acute pain Of these 32 studies only 9 involved intravenous forms of hydromorphone Of these 8 studies 5 involved patient controlled analgesia and only 1 study compared intravenous IV hydromorphone to IV morphine The Cochrane review concludes that there are gaps in the understanding of the efficacy and potency of hydromorphone Only 1 study of hydromorphone in the ED could be located and this compared IV hydromorphone versus IV meperidine in patients with ureteral colic Although this study showed hydromorphone was superior at all time periods and had fewer side effects the study used fixed doses of hydromorphone 1mg and meperidine 50mg
It has been the clinical experience of some ED physicians that hydromorphone may be a better opiate in patients presenting to the ED with acute pain Hydromorphone is also the opiate that is usually given if morphine does not adequately control a patients pain in the ED
Hydromorphone may also have other benefits such as a faster onset since it is more lipophilic than morphine and crosses the blood-brain barrier faster
If it is shown that hydromorphone gives better pain relief to patients with comparable or fewer side effects when compared with morphine then we may be able to provide evidence to suggest that hydromorphone should be the parenteral opiate of choice for adult ED patients presenting with acute pain of moderate to severe intensity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None