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Patients treated with protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg IV hydromorphone if the patient wants more) will have better pain relief and no more adverse events than patients receiving non-protocolized pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocolized | Experimental | 1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" |
|
| Nonprotocolized | Active Comparator | An IV opioid the type and dose of which will be determined by the treating clincian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline. | Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department). | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered.
Use of other opioids, tramadol, or heroin in the past seven days: to avoid introducing bias related to opioid tolerance that may alter the response to intravenous opioids thereby masking the effects of the medications administered.
Prior adverse reaction to morphine, hydromorphone, or other opioids: An exception will be if the patient has received opioid medications in the past without adverse event (i.e. a patient may state he is allergic to morphine but has received hydromorphone in the past without any adverse effects)
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months resulting in alteration in pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, migraine, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication may alter the perception, report, and treatment of pain. Alcohol intoxication will be determined to exist as judged by the treating physician.
Systolic Blood Pressure < 90 mm Hg: Opioids produce peripheral vasodilation that may result in orthostatic hypotension or syncope.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma.
Weight less than 100 pounds: we are concerned that hydromorphone in doses up to 2 mg may not be safe in patients weighing less than 100 lbs.
Baseline room air oxygen saturation less than 95%: since IV opioids may cause respiratory depression and result in hypoxemia, we are excluding this subgroup of patients.
C02 measurement greater than 46: In accordance with a similar study (04-12-360), four subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 4 subsets are as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Chang, M.D. | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Protocolized | 1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes |
| FG001 | Nonprotocolized | An IV opioid the type and dose of which will be determined by the treating clincian Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The difference between the number of participants who enrolled and completed the study and the number of participants analyzed is due to missing outcome data. There were 4 missing data from the Protocolized group, and 2 missing data from the Nonprotocolized group, for a total of 6 patients. These 6 patients were excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Protocolized | 1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes |
| BG001 | Nonprotocolized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline. | Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department). | Protocolized group had 4 missing outcome data, Nonprotocolized missing 2 outcome data. These 6 patients were excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
60 minutes after the last dose of opioids was given
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protocolized | 1mg IV hydromorphone followed by an additional 1mg at 15 minutes if the patient answer "yes" to the question, "Do you want more pain medication?" Hydromorphone: Hydromorphone 1mg IV, followed by an optional dose of 1mg IV hydromorphone 15 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen saturation <90% | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Chang, MD, MS | Department of Emergency Medicine, Albert Einstein College of Medicine | 718-920-7464 | achang@montefiore.org |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Nonprotocolized | Drug | An IV opioid the type and dose of which will be determined by the treating clinician |
|
|
An IV opioid the type and dose of which will be determined by the treating clincian Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Location of Pain | Count of Participants | Participants |
|
| Pain Intensity | Pain intensity is measured on a numerical rating score (NRS) scale of 0 ("no pain") to 10 ("worst pain imaginable"). This pain intensity measure is the pain intensity of the patient before treatment in the Emergency Department. | Count of Participants | Participants |
|
| Nausea/vomiting | Count of Participants | Participants |
|
| Analgesics taken at home | Count of Participants | Participants |
|
| OG001 | Nonprotocolized | An IV opioid the type and dose of which will be determined by the treating clincian Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician |
|
|
| Post-Hoc | Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone | Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). | Change in N from total analyzed (82 and 99 from 108 and 110 respectively) due to looking at a subpopulation: those patients who only received 1 dose of IV hydromorphone, versus those who received 2 or more doses (see 3. Post Hoc Outcome). | Posted | Median | Standard Deviation | units on a scale | 60 minutes |
|
|
|
| Post-Hoc | Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone | Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). | Change in N from total analyzed (26 and 22 from 108 and 110 respectively) due to looking at a subpopulation: those patients who received 2 or more doses of IV hydromorphone, versus those who received only 1 dose (see 2. Post Hoc Outcome). | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
|
|
| Post-Hoc | Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine | Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 ("no pain") to 10 ("worst pain imaginable"). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). The comparison of hydromorphone to morphine is due to the wide use of morphine for pain management in the Emergency Department setting and the comparison of the two opioids in previous studies. | The Nonprotocolized group has a different value for participants analyzed for this section than the overall number of participants analyzed for the group (81 versus 110), because this is looking at only those patients who received IV morphine. Nonprotocolized left medication up to the doctor, and as such, some patients received different medication | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| 33 |
| 108 |
| EG001 | Nonprotocolized | An IV opioid the type and dose of which will be determined by the treating clincian Nonprotocolized: An IV opioid the type and dose of which will be determined by the treating clinician | 0 | 110 | 0 | 110 | 27 | 110 |
| Oxygen saturation 90-94% | Respiratory, thoracic and mediastinal disorders |
|
| Pulse rate <60 beats/min | Vascular disorders | excludes patients with baseline pulse below 60 beats/min |
|
| Systolic blood pressure <90 mmHg | Vascular disorders |
|
| Respiratory rate <12 breaths /min | Respiratory, thoracic and mediastinal disorders |
|
| Nausea | Gastrointestinal disorders | excludes patients who were nauseated or had vomited before first dose of IV opioid |
|
| Vomiting | Gastrointestinal disorders | excludes patients who were nauseated or had vomited before first dose of IV opioid |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |