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Trial record 46 of 195 for:    Hemorrhage AND SAH

Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT02330094
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
William D. Freeman, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Drug: Gabapentin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Study Start Date : December 2014
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Headache

Arm Intervention/treatment
Experimental: Gabapentin
Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Drug: 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.

Other Name: Neurontin

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





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330094


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: William Freeman, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by William D. Freeman, Mayo Clinic:

Additional Information:
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Responsible Party: William D. Freeman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02330094     History of Changes
Other Study ID Numbers: 14-005288
First Posted: January 1, 2015    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Keywords provided by William D. Freeman, Mayo Clinic:
aSAH
SAH
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Headache
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents