Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aneurysmal Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Gabapentin

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.

Interventions

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Gabapentin

Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.

Intervention Type DRUG

Placebo

Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.

Both groups will receive other standard of care pain medications.

Intervention Type DRUG

Other Intervention Names

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Neurontin

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No