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Completed

NCT Number: NCT02330094

Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

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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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gabapentin

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.

Other names: Neurontin

Placebo

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.

Primary outcomes

  1. Average Numeric Pain Score

    Time frame: baseline through day 7

    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.

  2. Average Narcotic Consumption

    Time frame: baseline through day 7

    The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).

Secondary outcomes

  1. Pain Control Satisfaction Questionnaire

    Time frame: Day 8

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 1, 2015
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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