Clinical trial NCT02330094: Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Official title: Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: aSAH
SAH
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. The investigators plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, the investigators plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.

Eligibility criteria: 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)

Primary outcomes:
measure: Average Numeric Pain Score
timeFrame: baseline through day 7
measure: Average Narcotic Consumption
timeFrame: baseline through day 7
Secondary outcomes:
measure: Pain Control Satisfaction Questionnaire
timeFrame: Day 8
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: William Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhakal LP, Turnbull MT, Jackson DA, Edwards E, Hodge DO, Thottempudi N, Kamireddi P, Akinduro OO, Miller DA, Meschia JF, Freeman WD. Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study. Front Neurol. 2020 Jul 28;11:744. doi: 10.3389/fneur.2020.00744. eCollection 2020.