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Intrathecal baclofen
Best practices project
Troubleshooting
Michael Saulino, MD
PhD
Physiatrist
MossRehab
Elkins Park
My Disclosures
• Speaker’s bureau and clinical investigator
for Jazz Pharmaceuticals
• Speaker’s bureau and clinical investigator
for Medtronic, Inc
• Clinical investigator for Mallinckrodt
• Consultant for SPR therapeutics
• NANS Board of Directors
Objectives / Outline
• Review the techniques for evaluation and
management of optimal intrathecal
baclofen therapy
• Under-dosing
• Over-dosing
Important Caveat
• While this presentation (and related
manuscript) focus on device related issues, it is
important to recognize non-device related
issues that can present in a similar fashion
• Noxious stimuli can drive increased tone
• Disease progression or exacerbation can mimic
over or under dosing
Diagnostic evaluation process
• Targeted medical history
– onset, course, duration, exacerbating / relieving
factors of current presentation, associated symptoms
– Recent intrathecal history – last refill, last dosing
adjustment, last surgery, etc.
• Focused physical examination
– Vitals
– Neuromuscular exam
– Item relevant for potential noxious stimuli
Diagnostic evaluation process
• Judicious use of radiologic/laboratory testing
– Noxious stimuli search
– CK levels
– Newer Medtronic catheter is radiolucent
• Obtain current telemetry
– Compare to prior history
– Consider a bolus as a combined diagnostic /
therapeutic maneuver
• Check reservoir volume and compared to predicted
volume
Diagnostic evaluation process
• Catheter access port (CAP) aspiration
• Catheter dye study vs. CT myelogram
with dye injection through CAP
• Nuclear medicine cisternogram
• MRI of thoracic spine
Differential diagnosis: under dosing
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Other medications
Sepsis
Meningitis
Neuroleptic malignant syndrome
Autonomic dysreflexia
Serotonin syndrome
Malignant hyperthermia
Seizure disorder
Differential diagnosis: overdose
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Other medications
Sepsis
Intracranial hemorrhage
Hypoglycemia
Increased intracranial pressure (Cushing’s
triad)
• Electrolyte imbalance
• Seizure disorder
Under dose/withdrawal management
• Treatment occurs prior to or in parallel with
diagnostic workup
• Patient require monitoring (local resources)
• Tossup – triage/stabilize remotely vs.
immediate transport
• First line therapy: restoration of intrathecal
baclofen delivery
– Single vs multiple boluses
– LP, external catheter, new implanted system
Under dose/withdrawal management
• Restart dosing based on intensity and duration
of symptoms
• It intrathecal delivery cannot be achieved
promptly, oral medication can be used as
temporizing measure
• Oral baclofen is agent of choice but should not
be relied on to halt progressive withdrawal
• No uniform oral to intrathecal conversion
• Additional options include benzodiazepines (IV)
and cyproheptadine
Overdose management
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Support airway, respiration and circulation
Reduce or stop ITB delivery
Option: CSF drainage
Advise against physiostigmine
Watch for rebound withdrawal
Determine underlying cause
Emergency preparedness
• Structured, consistent on-call system including
off hours coverage
• Direct communication between the managing
clinician, implanting surgeon, emergency
department, and critical-care team
• Patients should be educated on the signs and
symptoms of over- and under dosing
• Patients in distress should call their managing
physician AND go directly to the ED
Summary
• Patients demonstrating suboptimal effects of
ITB therapy should be evaluated promptly with
a focused medical history, targeted physical
examination, system interrogation, and
radiologic testing.
• Patients can demonstrate adverse effects from
both over- and underdo sing. Clinicians
managing these patients should be familiar with
the evaluation and management of these
syndromes.
Summary
• Providers of ITB therapy should create on-call
and triage protocols for management of
adverse effects. Patients should be educated
on how to engage these protocols.