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The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.
Periodic reports are made to the IRB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm C Morphine | Active Comparator | Morphine given to trauma patients transported by helicopter |
|
| Arm D Fentanyl | Active Comparator | Fentanyl given to trauma patients transported by helicopter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| either fentanyl or morphine | Drug | either morphine 4mg IV or fentanyl 50mcg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Numeric Pain Score (NPS) From First to Last Dose | Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered. A significant mean pain score change is defined as greater than or equal to 2 Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain | Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group. |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of Instance of Narcotic Side Effects. | Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) . | Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Smith, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21689900 | Result | Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL. The effectiveness and adverse events of morphine versus fentanyl on a physician-staffed helicopter. J Emerg Med. 2012 Jul;43(1):69-75. doi: 10.1016/j.jemermed.2011.05.018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Morphine | Patients randomized on even days received Morphine 4mg IV |
| FG001 | Fentanyl | Patients randomized on odd days received Fentanyl 50mcg IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morphine | morphine for trauma patients transported by helicopter either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV |
| BG001 | Fentanyl | fentanyl for trauma patients transported by helicopter either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV |
| 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 | Mean Change in Numeric Pain Score (NPS) From First to Last Dose | Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered. A significant mean pain score change is defined as greater than or equal to 2 Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain | 4 subjects were excluded from analysis, 1 from the Morphine Group and 3 from the Fentanyl group to achieve the baseline participants for data analysis 103 morphine and 97 fentanyl. | Posted | Mean | Standard Deviation | score on a scale | Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group. |
|
1 hour
4 subjects were excluded from analysis, 1 from the Morphine Group and 3 from the Fentanyl group to achieve the baseline participants for data analysis 103 morphine and 97 fentanyl.
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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 4 mg iv | either fentanyl or morphine either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV |
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Power of study may be too low to determine small differences
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Emerman | Metrohealth Medical Center | 2167783577 | cemerman@metrohealth.org |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Initial Numeric Pain Score | Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain | Mean | Standard Deviation | units on a scale |
|
| Fentanyl |
Patients randomized on odd days received Fentanyl 50mcg IV |
|
|
| Secondary | Recording of Instance of Narcotic Side Effects. | Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) . | 4 subjects were excluded from analysis, 1 from the Morphine Group and 3 from the Fentanyl group to achieve the baseline participants for data analysis 103 morphine and 97 fentanyl. | Posted | Number | participants | Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects. |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Fentanyl 50mcg IV | either fentanyl or morphine either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV | 0 | 97 | 0 | 97 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |