Acute Pain
Conditions
Keywords
Elderly, Hydromorphone, Morphine, Pain, Acute, Emergency Department
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 patient's 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.
Interventions
0.05 mg/kg Intravenous
0.0075 mg/kg intravenous
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age greater than 65 years 2. Pain with onset within 7 days 3. ED attending physician's judgment that patient's pain warrants use of parenteral opioids 4. Normal mental status
Exclusion criteria
1. Prior use of methadone 2. Use of other opioids or tramadol within past seven days 3. Prior adverse reaction to morphine or hydromorphone 4. Chronic pain syndrome 5. Alcohol intoxication 6. Systolic Blood Pressure \<90 mm Hg 7. Use of monoamine oxidase (MAO) inhibitors in past 30 days 8. Elderly patients with a capnometry reading of greater than 46
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Baseline to 30 minutes after medication infused | Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Pain Score | Baseline to 30 minutes after medication infused | Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score. |
| Number of Participants With Pain Relief | 30 minutes after medication infused | Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused. |
| Number of Participants Satisfied With Pain Medication | 30 minutes after medication infused | Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morphine 0.05 mg/kg IV morphine | 90 |
| Hydromorphone 0.0075 mg/kg IV hydromorphone | 93 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing data collection instrument | 3 | 2 |
| Overall Study | Missing outcome data | 3 | 2 |
| Overall Study | Participant too young | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Hydromorphone | Morphine |
|---|---|---|---|
| Age, Continuous | 75 years STANDARD_DEVIATION 8 | 74 years STANDARD_DEVIATION 8 | 76 years STANDARD_DEVIATION 8 |
| Baseline Pain Score 10 | 86 Participants | 46 Participants | 40 Participants |
| Baseline Pain Score 6 | 19 Participants | 10 Participants | 9 Participants |
| Baseline Pain Score 7 | 21 Participants | 9 Participants | 12 Participants |
| Baseline Pain Score 8 | 38 Participants | 18 Participants | 20 Participants |
| Baseline Pain Score 9 | 19 Participants | 10 Participants | 9 Participants |
| Number of participants experiencing nausea since pain began No | 96 Participants | 48 Participants | 48 Participants |
| Number of participants experiencing nausea since pain began Yes | 79 Participants | 38 Participants | 41 Participants |
| Number of participants experiencing vomiting since pain began No | 119 Participants | 60 Participants | 59 Participants |
| Number of participants experiencing vomiting since pain began Yes | 59 Participants | 29 Participants | 30 Participants |
| Number of participants who had pain in specific locations Abdomen/pelvis | 101 Participants | 56 Participants | 45 Participants |
| Number of participants who had pain in specific locations Back | 25 Participants | 7 Participants | 18 Participants |
| Number of participants who had pain in specific locations Chest | 6 Participants | 4 Participants | 2 Participants |
| Number of participants who had pain in specific locations Extremities | 13 Participants | 8 Participants | 5 Participants |
| Number of participants who had pain in specific locations Head/neck | 4 Participants | 2 Participants | 2 Participants |
| Number of participants who had pain in specific locations Other | 33 Participants | 15 Participants | 18 Participants |
| Number of participants who had pain in specific locations Unknown/missing data | 1 Participants | 1 Participants | 0 Participants |
| Number of participants who took analgesics before coming to the ED None | 141 Participants | 75 Participants | 66 Participants |
| Number of participants who took analgesics before coming to the ED Some | 42 Participants | 18 Participants | 24 Participants |
| Primary Language English | 102 Participants | 51 Participants | 51 Participants |
| Primary Language Other | 5 Participants | 0 Participants | 5 Participants |
| Primary Language Spanish | 73 Participants | 40 Participants | 33 Participants |
| Primary Language Unknown | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 49 Participants | 28 Participants | 21 Participants |
| Race/Ethnicity, Customized Hispanic | 86 Participants | 47 Participants | 39 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 45 Participants | 18 Participants | 27 Participants |
| Region of Enrollment United States | 183 Participants | 93 Participants | 90 Participants |
| Sex: Female, Male Female | 128 Participants | 65 Participants | 63 Participants |
| Sex: Female, Male Male | 55 Participants | 28 Participants | 27 Participants |
| Weight | 153 lbs STANDARD_DEVIATION 29 | 157 lbs STANDARD_DEVIATION 29 | 148 lbs STANDARD_DEVIATION 29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 93 |
| other Total, other adverse events | 14 / 90 | 23 / 93 |
| serious Total, serious adverse events | 0 / 90 | 0 / 93 |
Outcome results
Change in Pain Intensity
Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused
Time frame: Baseline to 30 minutes after medication infused
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine | Change in Pain Intensity | 3.3 units on a scale | Standard Deviation 2.5 |
| Hydromorphone | Change in Pain Intensity | 3.8 units on a scale | Standard Deviation 2.6 |
Number of Participants Satisfied With Pain Medication
Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair.
Time frame: 30 minutes after medication infused
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morphine | Number of Participants Satisfied With Pain Medication | Good to excellent | 56 Participants |
| Morphine | Number of Participants Satisfied With Pain Medication | Poor to fair | 34 Participants |
| Hydromorphone | Number of Participants Satisfied With Pain Medication | Good to excellent | 59 Participants |
| Hydromorphone | Number of Participants Satisfied With Pain Medication | Poor to fair | 34 Participants |
Number of Participants With a Change in Pain Score
Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.
Time frame: Baseline to 30 minutes after medication infused
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morphine | Number of Participants With a Change in Pain Score | less than 50% decrease | 53 Participants |
| Morphine | Number of Participants With a Change in Pain Score | greater than or equal to 50% decrease | 37 Participants |
| Hydromorphone | Number of Participants With a Change in Pain Score | less than 50% decrease | 53 Participants |
| Hydromorphone | Number of Participants With a Change in Pain Score | greater than or equal to 50% decrease | 40 Participants |
Number of Participants With Pain Relief
Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.
Time frame: 30 minutes after medication infused
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morphine | Number of Participants With Pain Relief | none or slight | 37 Participants |
| Morphine | Number of Participants With Pain Relief | moderate to complete | 53 Participants |
| Hydromorphone | Number of Participants With Pain Relief | none or slight | 32 Participants |
| Hydromorphone | Number of Participants With Pain Relief | moderate to complete | 61 Participants |