Phase 4
N=16
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02330094 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Average Numeric Pain Score — 5.2; 5.8 score on a scale — p=0.7
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Numeric Pain Score |
5.2; 5.8 | 0.7 |
| PRIMARY Average Narcotic Consumption |
19.4; 20.2 | 0.79 |
| SECONDARY Pain Control Satisfaction Questionnaire |
14; 12.6 | 0.66 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- 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)
- Have symptomatic headache
- Able to swallow and verbalize pain score
- No known allergy to gabapentin or fentanyl
- Numeric pain score ≥ 5
- Ability to provide written personal consent
Exclusion Criteria
- Gabapentin use prior to SAH admission
- Renal failure with creatinine clearance less than 30 mL/min
- Unable to receive standard of care pain medications
- Pregnant or breastfeeding patients
- History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV)
Data sourced from ClinicalTrials.gov (NCT02330094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.