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| ID | Type | Description | Link |
|---|---|---|---|
| 1856VC | Other Identifier | University of Kansas School of Medicine Wichita |
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| Name | Class |
|---|---|
| Ascension Health | INDUSTRY |
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The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, the investigators hope to:
Participants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours the patients are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of the patients regular medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine infusion | Patients will receive a 100 mg intravenous lidocaine bolus followed by an initial infusion at a rate of 2 mg∙kg -1∙h-1 based on ideal body weight. Lidocaine infusions will continue for a minimum of 1 h post-bolus. If headache numeric pain score decreases at all after initiation of infusion, then the rate will drop to 1 mg∙kg -1∙h-1. If headache numeric pain score starts increasing again, then the rate will return to 2 mg∙kg -1∙h-1, otherwise it will remain at 1 mg∙kg -1∙h-1 for up to 48 h. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain | Reduction of pain ≥ 2 points in the numeric pain score after lidocaine infusion treatment. The numeric pain score is a score rating severity of pain from 0 to 10, with higher scores meaning worse pain. The reduction in pain scores indicates a decrease in severity of pain. | Benefit should be seen within first 24 h of infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of vasospasm | Observe the prevalence of vasospasm in participants that receive lidocaine infusion | Within the first 7 days participants are receiving treatment |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited once a diagnosis of non-traumatic subarachnoid hemorrhage has been confirmed and the patients meet the inclusion criteria for the study. The investigators will exclude incarcerated patients and pregnant women from the study, but the investigators will include patients that cannot consent themselves, as long as the patient meets the inclusion criteria, the investigators can gain consent from the patient's legal guardian/representative, and the patient can report a numeric pain score for the full length of the study (every 2 h the patient is awake for up to 7 days).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William L Krogman, MS | Contact | 316-268-6156 | wkrogman@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Salgado, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Via Christi St. Francis | Recruiting | Wichita | Kansas | 67214 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D006261 | Headache |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| D012816 | Signs and Symptoms |