Fixed Dose of Intravenous Hydromorphone in the Treatment of Acute Pain
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|ClinicalTrials.gov Identifier: NCT01006850|
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : July 20, 2011
Research question: In adult emergency department (ED) patients to whom the attending ED physician has decided to administer intravenous opioid pain control:
- What is the incidence of serious adverse events, defined as the use of naloxone, up to a total of 2 hours after infusion of 2 mg IV hydromorphone?
- What is the incidence of other side effects (respiratory depression, hypotension, oxygen desaturation, nausea, vomiting, and pruritus) at 5, 15, 30 and 120 minutes post infusion of 2mg IV hydromorphone?
- What is the speed of onset of 2 mg IV hydromorphone? This will be measured by asking the patient for his NRS pain score at 1, 2, 3, 4, and 5 minutes post infusion of 2 mg IV hydromorphone.
- What is the incidence of administration of rescue medications?
- For those patients who decline to enter the study, what are their reasons for refusal (e.g. fear of becoming addicted)? The investigators believe this is yet another barrier to providing adequate pain relief for patients with acute severe pain.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Hydromorphone||Phase 4|
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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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2005|
|Primary Completion Date :||May 2007|
|Study Completion Date :||May 2007|
Experimental: 2 mg IV hydromorphone
2 mg IV hydromorphone
2mg IV hydromorphone
Other Name: Dilaudid
- The incidence of a serious adverse event by 120 minutes post infusion, which is defined as the use of naloxone as a reversal agent. [ Time Frame: 120 minutes ]
- Respiratory depression: RR < 12 breaths per minute will be considered a less serious adverse event. [ Time Frame: 120 minutes ]
- Oxygen desaturation: The RAs will note the presence of oxygen desaturation, defined as a pulse oximeter reading less than 90% or a decrease of 5% or more from baseline, at the following time points: baseline, 1, 2, 3, 4, 5, 15, 30 and 120 minutes. [ Time Frame: 120 minutes ]
- Hypotension: Systolic BP less than 90 mg Hg will be counted as a less serious adverse event. [ Time Frame: 120 minutes ]
- Vomiting: Patients will be asked whether they vomited during the following time intervals: pre-baseline, baseline-5 minutes, 6 minutes to 15 minutes, 16 minutes to 30 minutes, and 31 minutes to 2 hours. [ Time Frame: 120 minutes ]
- Nausea: We will use the recently validated quantitative nausea visual analog scale (VAS) (Hendey 2005). [ Time Frame: 120 minutes ]
- Pruritis: Patients will be asked whether they experience pruritus at the following time intervals: pre-baseline, baseline-5 minutes, 6 minutes to 15 minutes, 16 minutes to 30 minutes, and 31 minutes to 2 hours. [ Time Frame: 120 minutes ]
- The RAs will assess the incidence of other adverse events such as falling by observation and by reviewing the nursing notes and chart, as well as by asking the patient's providers. [ Time Frame: 120 minutes ]
- Speed of onset of analgesia: Speed of onset of analgesia will be assessed by eliciting self-reported pain scores every minute for 5 minutes post infusion of hydromorphone. [ Time Frame: 120 minutes ]
- A numerical rating scale ranging from 0 = no pain, to 10 = worst pain possible will be used to measure self-reported pain. [ Time Frame: 120 minutes ]
- Speed of onset of analgesia will also be assessed by a 5-point pain relief scale. [ Time Frame: 120 minutes ]
- Patient Satisfaction Scale: Assessed using a 6-point patient satisfaction scale. [ Time Frame: 120 minutes ]
- Supplementary dose of opioid and non-opioid analgesics: The number of patients who receive supplementary pain medications as well as the total additional amount (mg) received. [ Time Frame: 120 minutes ]
- All medications administered to the patients and the time of administration will be recorded. Data from any patients who are given other opioids will be used up until the time the second opioid is administered [ Time Frame: 120 minutes ]
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): NCT01006850
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006850
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Andrew Chang, MD||Montefiore Medical Center|