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Transcript of What A Headache! - henryfordem.com in the ED 85% of adults –at least occasionally –c/o headaches...
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What A Headache!
Theresa Biesiada
March 8, 2012
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Objectives
Describe the EM relevance of headaches and migraines
Discuss the rationale for steroid therapy
Review the evidence
Conclusions
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My inspiration
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Headache in the ED
85% of adults – at least occasionally – c/o headaches
“Chief Complaint” of 2-5% of all ED visits
Vast majority are primary headache disorders
Tension-type (~50%)
Migraine (~10%)
Mixed – Type (~30%)
Secondary headaches ~ 10%
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Headache in the ED
ED management
Exclude secondary causes
SAH, infection, tumor, etc
Treat symptoms
Create a plan for discharge
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Migraine Headache
Recurring, unilateral headache
Lasts 4-72 hours untreated
Moderate to severe intensity
Worse with activity
Associated with N/V, photophobia,
phonophobia
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Migraine Headache
Affects 25% of women
Less common in men
Underdiagnosed, undertreated…
Most patients with migraines do not
come to the ER
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Migraine Headache in the ED
ED use for migraine
“First or worst” headache
Needs a diagnostic evaluation for
secondary cause
“Last straw” headache – unremitting
exacerbation of headache disorder
Frequent presenters
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Migraine Headache in the ED
Parenteral therapy better
GI effects of migraine – stasis and
delayed absorption
Migraine-specific therapy
Triptan – Sumatriptan 6mg subQ
Ergot – DHE 0.5-1mg IVPB
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Migraine Headache in the ED
Antiemetics
Dopamine antagonists are best (Reglan, Compazine)
NSAIDs
Used for outpatient therapy
Can give Toradol IV or IM
IV Hydration
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Migraine Headache in the ED
Opioids
Can be used for migraine
Other agents better
Side effects, abuse potential
Increased chance of revisit and
recurrence
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Tension-Type Headache
Bilateral
Pressing or tightening
Mild-moderate intensity
Absence of N/V, photophobia,
functional disability
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Tension-Type Headache
Along the migraine spectrum?
Same medications work
Patients can fit diagnostic criteria for
both
NSAIDS
Antiemetics
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Recurrence of Benign Headache
Within 24-72 hrs:
8-66% of migraines recur
20-25% of tension headaches recur
Of all headaches, about 35-50% recur
Less if headache is gone at discharge
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Why do we get headaches?
Vascular changes
Hormones
Inflammation
Increasingly thought to be very
important in migraine pathophysiology
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Inflammation in Benign Headaches
Traditional ED therapy treats pain and
nausea (NSAID-antiemetic)
Abortive therapy treats hormonal
changes (triptans, DHE)
Inflammation has not been targeted
aggressively
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The Question Today
Does administration of steroids prior to
discharge decrease the recurrence rate
of benign headache?
Controversial
We will discuss evidence on both sides!
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But first, a methodology
quandary…
We are looking at steroid administration
as an adjunctive therapy as part of a
discharge plan
This is concurrent or after
administration of symptom relief
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But first, a methodology
quandary… Should studies standardize headache treatment?
Pro: No confounding from other meds administered
Con: Unrealistic; may deter enrollment
Or should therapy be at physician discretion?
Pro: Reflects normal practice; does not discourage physicians from enrolling patients
Con: Other meds may have effect on recurrence rates
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CJEM 2006
Type: RDBCT
Setting: Two urban academic EDs in Texas
Patients: 55
Therapy: At physician discretion
Intervention: 10mg IV Decadron vs placebo
Results: Phone call 48-72h post ED discharge
Recurrence = Worse/unchanged/returned HA
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CJEM 2006 - Patients
Convenience sample
Inclusion: >18yo, benign headache, IV established, safe for discharge home
Exclusion: pregnant, fever, meningismus, focal signs, allergy, active PUD, DM 1, systemic fungal infection
Also excluded if already on steroids or already in study group
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CJEM 2006 - Methods
Randomized by pharmacist prior to
enrollment
Either saline or Decadron 10 mg given
by blinded RN
Patients contacted in 48-72h for
headache recurrence and side effects
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CJEM 2006 - Methods
Patients did not differ in demographics
or in other medications received
Interim analysis with highly significant
results – terminated early
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CJEM 2006 - Results
Study Control P value
Headache
recurrence
9.7% 58.3% P<0.001
Severe
recurrence
12.9% 33.3% P=0.14
Side effects 19.4% 20.8% P=1
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CJEM 2006 - Discussion
Strongly positive study
Limitations:
Very small study
Convenience sample
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Am J EM 2007 Type: RDBCT
Setting: community ED and academic ED in southeast Michigan
Patients: 115
Therapy: At physician discretion
Intervention: 24 mg Decadron vs placebo
Results: Headache recurrence 3 and 30 days after ED visit
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Am J EM 2007- Methods
Blinded randomized study packets
Inclusion: exacerbation of migraine,
meeting IHS criteria; need an IV
Exclusion: pregnant, fever, allergy to
steroids, GI bleeding, diabetes, acute
neuro deficit, recent steroid use
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Am J EM 2007 - Methods
Randomized by study pharmacist
Administered by blinded RN
Phone followup
Assessed recurrence at 3 and 30 days
Assessed functional disability
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Am J EM 2007 - Results
Study Control P Value
Recurrence
of headache
– 3 day
36.8% 42.9% P=0.6776
Resolution
of headache
– 3 day
47.3% 35.7% P=0.305
Recurrence
of headache
– 30 day
42.9% 47.5% p=0.682
Side effect –
dizziness
16.1% 2.5% P=0.040
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Am J EM 2007 - Discussion
Negative study
All outcomes with nonsignificant trends towards improvement with Decadron
Limitations:
Small study
Significant number of dropouts (19/115 = 17% - more in the placebo group)
Large dose of Decadron
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Neurology 2007
Type: RDBCT
Setting: 4 urban EDs in NYC
Patients: 205
Therapy: All received IV reglan
Further therapy at physician discretion
Intervention: 10 mg IV Decadron vs placebo
Results: Persistently pain free; functional disability
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Neurology 2007 – Patients
Convenience screening by RA’s
Inclusion: IHS migraine criteria
Exclusion: Pregnancy, lactation, fever,
focal neurological signs, LP planned,
allergy/intolerance to study medication
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Neurology 2007 - Methods
Randomization by study pharmacist
Medication or placebo given by blinded
RN
Assessment Q30min x 2 hours
Assessment at 24h by phone
No demographic differences
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Neurology 2007 - Outcomes
Pain rated none/mild/moderate/severe
Outcomes
Persistent pain free
Persistent headache relief
Mod/severe → none/mild
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Neurology 2007 - Results
Study Control P value
Persistent pain
relief
25% 19% 0.34
Subgroup with
HA >72hours
38% 13% 0.06
Normal
functionality
67% 59% 0.20
Require d
rescue
medication
13% 13% 1
Side effects 39% 26% 0.08
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Neurology 2007 - Discussion
Results with nonsignificant trend toward less headache persistence and less functional disability
Limitations:
Standardized medication regimen
Did not use a numerical pain scale – more subjective “none-mild-moderate-severe”
Underpowered for degree of difference seen
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Headache 2008
Type: RDBCT
Setting: 4 EDs in Edmonton, Canada
Patients: 126
Therapy: At physician discretion
Intervention: 15 mg Decadron vs placebo
Results: Recurrence of headache at 48-72h and 7 days
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Headache 2008 - Patients
Convenience sample
Inclusion: >18yo, hx of migraine, IHS
criteria, IV established
Exclusion: Pregnant, diabetic, PUD,
allergic to steroids, already receiving
steroids, immunosuppressed
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Headache 2008 - Methods
Phone contact at 72h and at 7 days
Rate headache
Describe recurrence
Describe functional impairment
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Headache Article - Results
Study Control OR
Recurrence
within 72
hours
22% 32% 0.6
(CI 0.3-1.3)
Recurrence
within 7
days
28% 40% 0.6
(CI 0.3-1.3)
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Headache 2008 – Discussion
Trend towards benefit at 3 and 7 days
Limits:
Convenience sample
Small
Underpowered
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EMJ 2008 Type: RDBCT
Setting: 3 community teaching EDs in Australia
Patients: 63
Therapy: Compazine/Thorazine + IVF
Intervention: 8 mg PO Decadron vsplacebo
Results: Recurrence of headache at 48-72h
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EMJ 2008 – Patients
Convenience sample
Inclusion: Age >17, diagnosis of migraine by a physician, exacerbation of migraine
Exclusion: “Findings inconsistent with migraine,” pregnancy, PUD, Type 1 DM, currently on steroids, allergic to steroids, prior enrollment, active fungal infection, headache requiring hospital admission
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EMJ 2008 – Methods
Randomization by study pharmacist
Assessment at 48-72 hr by phone
All patients got Compazine or Thorazineand IVF
Blinded RN administered study medication or placebo
Recurrence if patient had return of headache or it worsened >2 points on VAS
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EMJ 2008 - Results
Study Control P value
Recurrence 27% 39% 0.47
Subgroup with
headache <24h
15% 45% 0.08
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EMJ 2008 - Discussion
Nonsignificant trend towards improvement in decadron group
Limitations:
Excluded patients who had “findings inconsistent with migraine” but did not specify – selection bias?
Small study
Underpowered
Convenience study
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JEM 2011 Type: RDBCT
Setting: Suburban community hospital in New Jersey
Patients: 181
Therapy: At physician discretion
Intervention: 10 mg IV Decadron or 40 mg PO prednisone x 2 days vs placebo
Results: Recurrence of headache at 48-72h
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JEM 2011 - Patients
Consecutive patients screened
Inclusion: >17y, clinical dx of migraine
Exclusion: pregnancy, fever,
meningismus, atypical symptoms,
uncontrolled DM or HTN, PUD, allergy
to lactulose or steroids
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JEM 2011 - Methods
Randomized by study pharmacist
Administered by blinded RN
Assessment by VAS pre/post therapy
Phone followup 24-72h
Resolution of headache post discharge
Resolution with pain =0
Recurrence with pain ≥ moderate
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JEM 2011 – Results
Study Control P value
Recurrence 22%
Prednisone 17%
Decadron 27%
32% 0.21
Resolution in
ED
51% 49% 0.56
Rescue meds 36% 44% 0.42
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JEM 2011 - Discussion
Nonsignificant trend towards
improvement in both arms of study
Limitations:
Convenience sample
Lactulose as placebo
Underpowered
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Acad EM 2008
Type: Meta-analysis
Studies: Online search in multiple
databases
7 studies found for inclusion
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Acad EM 2008 - Selection Inclusion:
Blinded, randomized, controlled trial
Addressed migraine headache
Patients treated in the ED
Assessed steroid vs placebo
Evaluated for percentage/rate of headache recurrence in 24-72 hours
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Acad EM 2008 - Methods
Study validity assessed with Jadad
scoring
Assessed for blinding and
randomization
Data extracted and pooled
Pooled risk ratio calculated
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Acad EM 2008 - Results
Risk of recurrence 24-72 hours
RR 0.87
CI 0.8 – 0.95
9.7% risk reduction
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Acad EM 2008 - Results
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Acad EM 2008 - Discussion
Results become significant when all data pooled
Around 10% reduction in risk of recurrent headache
Limitations:
Data pooled
Different medication protocols and doses across studies
Most trials were convenience-sampled
Most trials allowed for physician discretion for treatment plan
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BMJ 2008
Type: Meta-analysis
Studies: Online search through several
online databases
7 trials included
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BMJ 2008 - Inclusion
Inclusion:
Randomized controlled trials
Assessed parenteral steroids
ED or urgent evaluation in headache clinic
Patients meeting criteria for migraine
Assessed 24-72h recurrence
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BMJ 2008 - Methods
Validity scoring
Data extracted and pooled
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BMJ 2008 - Results
Relative risk of recurrence
RR 0.74
CI 0.6 to 0.9
NNT = 9
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BMJ 2008 - Results
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BMJ 2008 – Dosage
Less than 15 mg Decadron
RR 0.8
CI 0.62 -1.04
More than 15 mg Decadron
RR 0.67
CI 0.5 – 0.91
Nonsignificant difference
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BMJ 2008 – Length of followup
Followup period <48h
RR 0.86
CI 0.66 – 1.11
Followup period >48h
RR 0.61
CI 0.45 – 0.84
Significant difference p=0.038
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BMJ 2008 - Discussion Results become significant when all data pooled
Around 26% reduction in risk of recurrent headache
NNT = 9
Limitations:
Data pooled
Different medication protocols and doses across studies
Most trials were convenience-sampled
Most trials allowed for physician discretion for treatment plan
Only assessed IV/IM steroids
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Final thoughts
Many studies address this question
Most of the RDBCTs negative
Most of the RDBCTs also
underpowered
Both meta-analyses show significant
results when data from the RDBCTs
pooled
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Final thoughts
Clinically significant results?
Studies with 10-48% reduction in risk of migraine recurrence
Meta-analyses with 10-25% reduction
Treat 5-10 patients to avoid 1 recurrence
Side effects of single dose Decadronminimal, rare and self limited in most studies
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Final thoughts
I plan to start adding this to my
treatment of uncomplicated migraine
pts
Probably will still not use for pregnant,
diabetic/immunocompromised
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Final thoughts
Questions?
Comments?
Thank you!
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References
Friedman and Grosberg. Diagnosis and Management of the Primary
Headache Disorders in the Emergency Department Setting. EM
Clinics of North America, 2009; 27: 71-87.
Thomas, SH. Emergency Department Treatment of Migraine, Tension,
and Mixed-type Headache. JEM 1994; 12:657-64.
Ducharme, Beveridge, Lee, et al. Emergency management of migraine:
is the headache really over? Academic Emergency Medicine 1998;
5:899-905.
Marcus. Migraine and tension-type headaches: the questionable
validity of current classification systems. Clin J Pain 1992; 8: 28-36.
Waeber and Moskowitz. Migraine as an inflammatory disorder.
Neurology 2005; 64: S9-15.
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References
Baden and Hunter. Intravenous dexamethasone to prevent the recurrence of benign headache after discharge from the emergency department: a randomized, double-blind, placebo-controlled clinical trial. CJEM 2006; 8:393-400.
Taheraghdam et al. Intravenous Dexamethasone Versus morphine in relieving of acute migraine headache. Pakistani Journal of Biological Sciences 2011; 14:682-687.
Donaldson et al. Intravenous dexamethasone vs placebo as adjunctive therapy to reduce the recurrence rate of acute migraine headaches: a multicenter double-blinded placebo-controlled randomized clinical trial. Am J EM 2007:26:124-130.
Rowe et al. Randomized controlled trial of intravenous dexamethasone to prevent relapse in acute migraine headache. Headache 2008; 40:333-340.
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References
Friedman et al. Randomized trial of IV dexamethasone for acute migraine in the ED. Neurology 2007; 69:2038-44.
Kelly et al. Impact of oral Decadron versus placebo after ED treatment of migraine with phenothiazines on the rate of recurrent headache; a randomized controlled trial. EMJ 2008; 25:26-29.
Flesseler et al. Steroids for migraine headaches: a randomized double blinded two-armed placebo controlled trial. JEM 2011; 40:463-68.
Singh et al. Does the Addition of Dexamethasone to Standard Therapy for Acute Migraine Headache Decrease the Incidence of Recurrent Headache for Patients Treated in the Emergency Department? A Meta-analysis and Systematic Review of the Literature. Acad EM 2008; 15:1223-33.
Colman et al. Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence. BMJ 2008; 336: 1359-67.