Aneurysmal Subarachnoid Hemorrhage Clinical Trial
Official title:
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Verified date | August 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 18 years of age or older 2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA) 3. Have symptomatic headache 4. Able to swallow and verbalize pain score 5. No known allergy to gabapentin or fentanyl 6. Numeric pain score = 5 7. Ability to provide written personal consent Exclusion Criteria: 1. Gabapentin use prior to SAH admission 2. Renal failure with creatinine clearance less than 30 mL/min 3. Unable to receive standard of care pain medications 4. Pregnant or breastfeeding patients 5. History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Numeric Pain Score | Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score. | baseline through day 7 | |
Primary | Average Narcotic Consumption | The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME). | baseline through day 7 | |
Secondary | Pain Control Satisfaction Questionnaire | The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction. | Day 8 |
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