Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305110
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2006-03-17
Brief Title:
Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute 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 study is to determine the safety and speed of onset of 2mg intravenous hydromorphone Dilaudid in patients weighing at least 150 lbs presenting to the emergency department with acute severe pain
Detailed Description:
Introduction and Background Pain is cited as the most frequent reason for visits to emergency departments EDs McCaig 2001 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 Ducharme 1996 Selbst 1990 Wilson 1989 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 Philips 2000
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 or delay early diagnosis and treatment and contribute to risks of tolerance and dependence in vulnerable patients
Morphine has long been considered the gold standard in pain control Hydromorphone is another powerful opioid 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 Quigley 2003 Of these 32 studies only 9 involved intravenous forms of hydromorphone Coda 1997 Collins 1996 Deutsch 1968 Jasani 1994 Liu 1995 Mahler 1975 Rapp 1996 Searle 1994 Urquhart 1988 Of these 8 studies 5 involved patient controlled analgesia and only 1 study compared IV hydromorphone to IV morphine Mahler 1975 The Cochrane review concludes that there are substantial gaps in the understanding of the efficacy and potency of hydromorphone
We have recently completed a study in non-elderly adult patients IRB 04-08-225 that showed that weight-based IV hydromorphone provides better pain relief than weight-based IV morphine This result was both statistically and clinically significant We also demonstrated in this same study that IV hydromorphone has a faster onset and also provided statistically significant improvement in pain relief at 5 minutes as compared to IV morphine
Although weight-based dosing of medications is common in pediatrics most emergency physicians use whole integer amounts of pain medications IV hydromorphone is more potent than IV morphine so the dosages given are much smaller We therefore wish to give a standard 2 mg dose of IV hydromorphone to all non-elderly adult patients weighing at least 150 lbs presenting to the ED with acute severe pain We wish to examine the safety and speed of onset of hydromorphone using such a protocol
Our general thought is that to develop more evidence based practice we need to generate more practice based evidence This study attempts to do this as it is practiced based and very practical We wish to take the drug as it comes 2mg Dilaudid in an ampule and use all of it thus alleviating the need to waste the excess opioid and alleviating the need to find a second person to witness the wasting We also wish to use a weight cutoff that everyone can remember 150 lbs We believe that this protocol will provide greater pain relief and help address the issue of inadequate pain treatment or oligoanalgesia that is prominent in the literature Sobel 2002 Wilson 1989 Goldfrank 2000
Finally in our multiple studies of pain conducted in the ED we have found a relatively high rate of refusal to receive pain medication We think this may represent a component to the problem of oligoanalgesia that is widespread in the ED We wish to investigate the reasons for patient refusal to receiving parental opioid medications fear of addiction side effects etc
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 or delay early diagnosis and treatment and contribute to risks of tolerance and dependence in vulnerable patients
Morphine has long been considered the gold standard in pain control Hydromorphone is another powerful opioid 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 Quigley 2003 Of these 32 studies only 9 involved intravenous forms of hydromorphone Coda 1997 Collins 1996 Deutsch 1968 Jasani 1994 Liu 1995 Mahler 1975 Rapp 1996 Searle 1994 Urquhart 1988 Of these 8 studies 5 involved patient controlled analgesia and only 1 study compared IV hydromorphone to IV morphine Mahler 1975 The Cochrane review concludes that there are substantial gaps in the understanding of the efficacy and potency of hydromorphone
We have recently completed a study in non-elderly adult patients IRB 04-08-225 that showed that weight-based IV hydromorphone provides better pain relief than weight-based IV morphine This result was both statistically and clinically significant We also demonstrated in this same study that IV hydromorphone has a faster onset and also provided statistically significant improvement in pain relief at 5 minutes as compared to IV morphine
Although weight-based dosing of medications is common in pediatrics most emergency physicians use whole integer amounts of pain medications IV hydromorphone is more potent than IV morphine so the dosages given are much smaller We therefore wish to give a standard 2 mg dose of IV hydromorphone to all non-elderly adult patients weighing at least 150 lbs presenting to the ED with acute severe pain We wish to examine the safety and speed of onset of hydromorphone using such a protocol
Our general thought is that to develop more evidence based practice we need to generate more practice based evidence This study attempts to do this as it is practiced based and very practical We wish to take the drug as it comes 2mg Dilaudid in an ampule and use all of it thus alleviating the need to waste the excess opioid and alleviating the need to find a second person to witness the wasting We also wish to use a weight cutoff that everyone can remember 150 lbs We believe that this protocol will provide greater pain relief and help address the issue of inadequate pain treatment or oligoanalgesia that is prominent in the literature Sobel 2002 Wilson 1989 Goldfrank 2000
Finally in our multiple studies of pain conducted in the ED we have found a relatively high rate of refusal to receive pain medication We think this may represent a component to the problem of oligoanalgesia that is widespread in the ED We wish to investigate the reasons for patient refusal to receiving parental opioid medications fear of addiction side effects etc
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