Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02330094

14-005288

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.

Treatment:

Drug: Gabapentin

Control

Placebo Comparator group

Description:

Placebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.

Treatment:

Drug: Placebo