Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Average Numeric Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Gabapentin
Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
干预措施: Gabapentin (Drug)
Control
Placebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
干预措施: Placebo (Drug)
结局指标
主要结局
Average Numeric Pain Score
时间窗: 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.
Average Narcotic Consumption
时间窗: baseline through day 7
The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).
次要结局
- Pain Control Satisfaction Questionnaire(Day 8)