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Inclusion criteria were too strict and therefore we were not able to recruit more patients.
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Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group / Standard of Care | Active Comparator |
|
|
| Low dose IV fentanyl PCA | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose fentanyl PCA | Drug |
| ||
| Standard IV fentanyl bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS). | Pain score 0-10. 0 represented no pain and 10 worst pain | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group / Standard of Care |
Standard IV fentanyl bolus |
| FG001 | Low Dose IV Fentanyl Patient Controlled Analgesia (PCA) |
Low dose fentanyl PCA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group / Standard of Care |
Standard IV fentanyl bolus |
| BG001 | Low Dose IV Fentanyl PCA |
| 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 | Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS). | Pain score 0-10. 0 represented no pain and 10 worst pain | Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results. | Posted | No | 4 days |
|
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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 | Control Group / Standard of Care |
Standard IV fentanyl bolus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alex Coon | Johns Hopkins School of Medicine | 410-955-2438 | acoon2@jhmi.edu |
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| Drug |
|
Low dose fentanyl PCA |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Low dose fentanyl PCA
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Low Dose IV Fentanyl PCA |
Low dose fentanyl PCA | 0 | 1 | 0 | 1 | 0 | 1 |
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