Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study

Introduction: Severe, often sudden-onset headache is the principal presenting symptoms of aneurysmal subarachnoid hemorrhage (aSAH). We hypothesized that gabapentin would be safe and tolerable for aSAH-induced headaches and would reduce concurrent opioid use.Methods: We performed a single-center, do...

Full description

Bibliographic Details
Main Authors: Laxmi P. Dhakal, Marion T. Turnbull, Daniel A. Jackson, Emily Edwards, David O. Hodge, Neeharika Thottempudi, Prasuna Kamireddi, Oluwaseun O. Akinduro, David A. Miller, James F. Meschia, William D. Freeman
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-07-01
Series:Frontiers in Neurology
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fneur.2020.00744/full
id doaj-137ee12620974bf0920ed052edbb9afd
record_format Article
spelling doaj-137ee12620974bf0920ed052edbb9afd2020-11-25T02:36:36ZengFrontiers Media S.A.Frontiers in Neurology1664-22952020-07-011110.3389/fneur.2020.00744541592Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot StudyLaxmi P. Dhakal0Laxmi P. Dhakal1Marion T. Turnbull2Daniel A. Jackson3Emily Edwards4David O. Hodge5Neeharika Thottempudi6Prasuna Kamireddi7Oluwaseun O. Akinduro8David A. Miller9James F. Meschia10William D. Freeman11William D. Freeman12William D. Freeman13Department of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Critical Care Medicine, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Pharmacy, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDivision of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurologic Surgery, Mayo Clinic, Jacksonville, FL, United StatesDivision of Neuroradiology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurology, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Critical Care Medicine, Mayo Clinic, Jacksonville, FL, United StatesDepartment of Neurologic Surgery, Mayo Clinic, Jacksonville, FL, United StatesIntroduction: Severe, often sudden-onset headache is the principal presenting symptoms of aneurysmal subarachnoid hemorrhage (aSAH). We hypothesized that gabapentin would be safe and tolerable for aSAH-induced headaches and would reduce concurrent opioid use.Methods: We performed a single-center, double-blind, randomized, placebo-controlled trial (registered at ClinicalTrials.gov; NCT02330094) from November 24, 2014, to June 24, 2017, where aSAH patients received either dose-escalating gabapentin or oral placebo, both alongside a standard of care pain regimen. After 7 days, patients had the option to continue in an open-label period until 14 days after enrollment or until discharge from the intensive care unit. Our primary endpoint was the efficacy of gabapentin in reducing headache numeric pain scores and opioid usage in patients with aSAH compared to the placebo group. We identified 63 potential patients with aSAH for the study. After applying stringent exclusion criteria, 16 eligible patients were enrolled into one of two arms.Results: The study ended prematurely after reaching a pre-specified funding period and an unexpected drop in aSAH cases. There was a trend toward lower headache numeric pain scores and opioid use in the gabapentin treated arm; however this was not significantly different. Gabapentin was well tolerated by participants and no adverse effects were reported.Conclusions: While there was a trend toward lower pain scores and opioid requirement in the gabapentin group, the study was underpowered to detect a difference. Larger multicenter trials are required to evaluate the efficacy of gabapentin to reduce opioid requirements after aSAH.https://www.frontiersin.org/article/10.3389/fneur.2020.00744/fullaneurysmal subarachnoid hemorrhagegabapentinheadachenumeric pain scoresopioid
collection DOAJ
language English
format Article
sources DOAJ
author Laxmi P. Dhakal
Laxmi P. Dhakal
Marion T. Turnbull
Daniel A. Jackson
Emily Edwards
David O. Hodge
Neeharika Thottempudi
Prasuna Kamireddi
Oluwaseun O. Akinduro
David A. Miller
James F. Meschia
William D. Freeman
William D. Freeman
William D. Freeman
spellingShingle Laxmi P. Dhakal
Laxmi P. Dhakal
Marion T. Turnbull
Daniel A. Jackson
Emily Edwards
David O. Hodge
Neeharika Thottempudi
Prasuna Kamireddi
Oluwaseun O. Akinduro
David A. Miller
James F. Meschia
William D. Freeman
William D. Freeman
William D. Freeman
Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
Frontiers in Neurology
aneurysmal subarachnoid hemorrhage
gabapentin
headache
numeric pain scores
opioid
author_facet Laxmi P. Dhakal
Laxmi P. Dhakal
Marion T. Turnbull
Daniel A. Jackson
Emily Edwards
David O. Hodge
Neeharika Thottempudi
Prasuna Kamireddi
Oluwaseun O. Akinduro
David A. Miller
James F. Meschia
William D. Freeman
William D. Freeman
William D. Freeman
author_sort Laxmi P. Dhakal
title Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
title_short Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
title_full Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
title_fullStr Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
title_full_unstemmed Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
title_sort safety, tolerability, and efficacy of pain reduction by gabapentin for acute headache and meningismus after aneurysmal subarachnoid hemorrhage: a pilot study
publisher Frontiers Media S.A.
series Frontiers in Neurology
issn 1664-2295
publishDate 2020-07-01
description Introduction: Severe, often sudden-onset headache is the principal presenting symptoms of aneurysmal subarachnoid hemorrhage (aSAH). We hypothesized that gabapentin would be safe and tolerable for aSAH-induced headaches and would reduce concurrent opioid use.Methods: We performed a single-center, double-blind, randomized, placebo-controlled trial (registered at ClinicalTrials.gov; NCT02330094) from November 24, 2014, to June 24, 2017, where aSAH patients received either dose-escalating gabapentin or oral placebo, both alongside a standard of care pain regimen. After 7 days, patients had the option to continue in an open-label period until 14 days after enrollment or until discharge from the intensive care unit. Our primary endpoint was the efficacy of gabapentin in reducing headache numeric pain scores and opioid usage in patients with aSAH compared to the placebo group. We identified 63 potential patients with aSAH for the study. After applying stringent exclusion criteria, 16 eligible patients were enrolled into one of two arms.Results: The study ended prematurely after reaching a pre-specified funding period and an unexpected drop in aSAH cases. There was a trend toward lower headache numeric pain scores and opioid use in the gabapentin treated arm; however this was not significantly different. Gabapentin was well tolerated by participants and no adverse effects were reported.Conclusions: While there was a trend toward lower pain scores and opioid requirement in the gabapentin group, the study was underpowered to detect a difference. Larger multicenter trials are required to evaluate the efficacy of gabapentin to reduce opioid requirements after aSAH.
topic aneurysmal subarachnoid hemorrhage
gabapentin
headache
numeric pain scores
opioid
url https://www.frontiersin.org/article/10.3389/fneur.2020.00744/full
work_keys_str_mv AT laxmipdhakal safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT laxmipdhakal safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT mariontturnbull safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT danielajackson safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT emilyedwards safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT davidohodge safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT neeharikathottempudi safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT prasunakamireddi safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT oluwaseunoakinduro safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT davidamiller safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT jamesfmeschia safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT williamdfreeman safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT williamdfreeman safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
AT williamdfreeman safetytolerabilityandefficacyofpainreductionbygabapentinforacuteheadacheandmeningismusafteraneurysmalsubarachnoidhemorrhageapilotstudy
_version_ 1724799228703670272