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Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. |
|
| B | Active Comparator | Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine PCA | Drug | Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Assessment by Patient | Nausea scale range: (0 = none, 10 = the worst), ordinal. | 1 hour after surgery, 8 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale | The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst). | 1 hour after surgery, 8 hours after surgery |
| Pain Assessment by Patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Flood, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Presbyterian Hospital | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18806056 | Result | Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb. |
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Double blind randomized controlled trial. Patients under 18, with chronic pain or on pain medication before surgery were excluded.
Adults having general surgery at Columbia University Medical Center (CUMC) were randomly assigned to receive Patient-Controlled Analgesia (PCA) with morphine or hydromorphone
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| ID | Title | Description |
|---|---|---|
| FG000 | Morphine PCA | Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes |
| FG001 | Hydromorphone PCA | Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morphine PCA | Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes |
| BG001 | Hydromorphone PCA | Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Nausea Assessment by Patient | Nausea scale range: (0 = none, 10 = the worst), ordinal. | Intention to treat (ITT) | Posted | Mean | Standard Deviation | Units on a scale | 1 hour after surgery, 8 hours after surgery |
|
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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 | Morphine PCA | Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes |
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This was a small study under typical clinical conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Flood | Columbia University | 201-370-3933 | pflood@stanford.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D009325 | Nausea |
| D014839 | Vomiting |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Hydromorphone PCA | Drug | hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml |
|
|
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
| 1 hour after surgery, 8 hours after surgery |
| The Number of Patients Who Vomited | 1 hour after surgery, 8 hours after surgery |
| Mean Score on the Ramsey Scale of Sedation | The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response). | 1 hour after surgery, 8 hours after surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale | The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst). | Posted | Mean | Standard Deviation | Units on a scale | 1 hour after surgery, 8 hours after surgery |
|
|
|
| Secondary | Pain Assessment by Patient | Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal. | Posted | Mean | Standard Deviation | Units on a scale | 1 hour after surgery, 8 hours after surgery |
|
|
|
| Secondary | The Number of Patients Who Vomited | Posted | Number | participants | 1 hour after surgery, 8 hours after surgery |
|
|
|
| Secondary | Mean Score on the Ramsey Scale of Sedation | The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response). | Posted | Mean | Standard Deviation | score on scale | 1 hour after surgery, 8 hours after surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Hydromorphone PCA | Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes | 0 | 25 | 0 | 25 |
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| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| 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 |