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This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro re nata (PRN) fentanyl | Active Comparator | A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. |
|
| Intravenous Patient-controlled Analgesia (IVPCA) fentanyl | Active Comparator | Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 25-50 mcg every 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Depression | Defined by minimum respiratory rate (breaths/minute). | up to 24 hours postoperatively |
| Respiratory Depression | Defined by maximal End Tidal CO2 (mmHg) | Up to 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia | Defined by minimum oxygen saturation (SaO2) | up to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fentanyl Consumption | Amount of cumulative fentanyl consumed in mcg | up to 24 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
pregnant women
patients with post operative neurological changes
patients who remain intubated post-operatively
patients who require the use of concomitant administration of sedatives
patients who have a history of narcotic abuse
patients who have a history of chronic pain requiring opioids
patients who have been in any investigational drug trial within 1 month of the treatment day
patients who have chronic respiratory insufficiency
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| Name | Affiliation | Role |
|---|---|---|
| Athir H Morad, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRN Fentanyl | A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. Fentanyl: 25-50 mcg every 20 minutes |
| FG001 | PCA Fentanyl | A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump. Fentanyl: 20mcg/demand dose with an 8 minute lock out |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRN Fentanyl | A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. Fentanyl: 25-50 mcg every 20 minutes |
| BG001 | IVPCA Fentanyl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number. |
| 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 | Respiratory Depression | Defined by minimum respiratory rate (breaths/minute). | Posted | Mean | Standard Error | breaths/minute | up to 24 hours postoperatively |
|
Adverse events were collected over the course of patient enrollment in the Neurosciences Critical Care Unit, within 24 hours of 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 | PRN Fentanyl | A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. Fentanyl: 25-50 mcg every 20 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Athir Morad, M.D. | Johns Hopkins University School of Medicine | 4109552611 | morada@jhmi.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | 20mcg/demand dose with an 8 minute lock out |
|
|
A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.
Fentanyl: 20mcg/demand dose with an 8 minute lock out
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | As the result of patients either not completing the assigned intervention due to premature withdrawal from the protocol, protocol violations, or incomplete data capture, the number of analyzed patients was reduced compared to the originally allocated number. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Respiratory Depression | Defined by maximal End Tidal CO2 (mmHg) | Posted | Mean | Standard Error | mmHg | Up to 24 hours postoperatively. |
|
|
|
| Secondary | Hypoxia | Defined by minimum oxygen saturation (SaO2) | Posted | Mean | Standard Error | Percent Oxygen Saturation | up to 24 hours postoperatively |
|
|
|
| Other Pre-specified | Mean Fentanyl Consumption | Amount of cumulative fentanyl consumed in mcg | Posted | Mean | Standard Error | micrograms/ hour | up to 24 hours postoperatively |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | PCA Fentanyl | A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump. Fentanyl: 20mcg/demand dose with an 8 minute lock out | 0 | 56 | 0 | 56 | 0 | 56 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |