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We are testing whether patients who received protocolized pain management (1 mg of IV hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later if the patients wants more) will have better pain relief and no more adverse events than patients receiving discretionary care, in which the patients receives whatever IV opioid the treating physician wants to give, in whatever dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protocolized | Experimental | 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" |
|
| Discretionary Care | Active Comparator | Patients receive an IV opioid the type and dose of which is determined by the treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Successful Treatment | Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes | As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes | 15 min |
| Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
Prior use of methadone.
Use of other opioids, tramadol, or heroin in the past seven days.
Prior adverse reaction to morphine, hydromorphone, or other opioids.
Chronic pain syndrome.
Alcohol intoxication.
Systolic Blood Pressure < 90 mm Hg.
Use of monoamine oxidase (MAO) inhibitors in past 30 days.
Weight less than 100 pounds.
Baseline room air oxygen saturation less than 95%.
C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, 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 K Chang, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center Emergency Department | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Protocolized | 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later |
| FG001 | Discretionary Care | Patients receive an IV opioid the type and dose of which is determined by the treating physician IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The discrepancy between the number of patients who completed the study and the number of patients included in analysis is due to missing data (6 Protocolized and 4 Discretionary) and participants enrolled more than once (2 Protocolized). These patients completed the study but had duplicate or missing data that could not be included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Protocolized | 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later |
| BG001 |
| 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 | Percentage of Patients With Successful Treatment | Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes | The discrepancy between the number of patients enrolled and randomized and the number of patients included in analysis is due to missing data (6 from Protocolized and 4 from Discretionary Care) and participants enrolled more than once (2 from Protocolized). | Posted | Number | Percentage of Participants | 60 minutes |
|
60 minutes
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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 | 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?" Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration of Naloxone | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Chang, MD, MS | Department of Emergency Medicine, Albert Einstein College of Medicine | 7189207464 | achang@montefiore.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| IV opioid | Drug | Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. |
|
|
Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment. |
| 60 minutes |
| Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient. | Up to 60 minutes |
| Discretionary Care |
Patients receive an IV opioid the type and dose of which is determined by the treating physician IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. |
| 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 | pounds |
|
| 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 | Count of Participants | Participants |
|
| Vomiting | Count of Participants | Participants |
|
| OG001 | Discretionary Care | Patients receive an IV opioid the type and dose of which is determined by the treating physician IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. |
|
|
| Secondary | Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes | As defined by the percentage of patients who answer "no" to the question, "Do you want more pain medication?" at 15 minutes | Posted | Number | Percentage of Participants | 15 min |
|
|
|
| Secondary | Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes | Patients who did not want pain medication determined by those who answered "no" to the question "do you want more pain medication?" at 60 minutes after treatment. | Posted | Number | percentage of participants | 60 minutes |
|
|
|
| Secondary | Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes). | Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The averages were calculated by finding the mean of change in pain intensity for each patient. | Posted | Mean | Standard Deviation | units on a scale | Up to 60 minutes |
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 22 |
| 167 |
| EG001 | Discretionary Care | Patients receive an IV opioid the type and dose of which is determined by the treating physician IV opioid: Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well. | 0 | 171 | 0 | 171 | 30 | 171 |
| Oxygen saturation <95% | Respiratory, thoracic and mediastinal disorders |
|
| Systolic blood pressure <90 mmHg | Vascular disorders |
|
| Respiratory rate <12 breaths/min | Respiratory, thoracic and mediastinal disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Nausea | Gastrointestinal disorders | excludes patients nauseated before intervention |
|
| Vomiting | Gastrointestinal disorders | excludes patients vomiting before the intervention |
|
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| 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 |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |