Oral Dexamethasone for Bronchiolitis: A randomized Trial
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Transcript of Oral Dexamethasone for Bronchiolitis: A randomized Trial
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Oral Dexamethasone for Bronchiolitis: A randomized TrialJournal club 20/2/14
Alansari K et al. Oral dexamethasone for bronchiolitis: a randomised trial. Pediatrics 2013 Oct;132(4):e810-6.
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Population• Qatar• 2010- 2012 (bronchiolitis seasons)• Infants ≤ 18 months• “moderate to severe” bronchiolitis (Wang score ≥ 4) • Bronchiolitis defined as viral URTI followed by wheezing
or crackles on auscultation• Hx of eczema or 1st degree relative with asthma• Exclusions:- any previous wheeze, 02 sats ≤85%
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Methods• Assess on the acute ward• CXR & NPA for every patient• Randomise (concealed envelopes)
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Intervention• 1mg/kg dexamethasone for one day• Then 0.6mg/kg per day for 4 days• Or placebo
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“Standard” Care• Salbutamol Nebs at 0, 30, 60, 120 minutes then every 2
hours throughout admission• Nebulsied Epinephrine 2.5- 5ml, if needed up to hourly
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Primary Outcome• Time from randomisation to ready for discharge as
deemed fit by Dr on call (all patients get 6hrly review)- Decided does not need O2, ? Sats ≥ 94% -
Feeding adequately- Minimal or absent wheezing, crackles or chest
recessions
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Secondary Outcomes• Need for epinephrine• Re-admission rates
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CASP
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Are the results valid?1. Did the trial address a clearly focused issue?
Yes
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Are the results valid?2. Was the assignment of patients to treatments randomised?
Yes
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Are the results valid?3. Were all the patients who entered the trial
accounted for at its conclusion?
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Is it worth continuing?4. Were patients, health workers and study personel “blind” to the treatment?
Yes
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5. Were the groups similar at the start of the trial?
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6. Aside from the intervention, were the groups treated equally?
?Yes
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What are the results?
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Will the results help locally??9. Can the results be applied in your context?
No• Not our standard care• Not our definition of bronchiolitis• Not same Dr levels/ review rates• Primary outcome definition unclear
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10. Were all clinically important outcomes considered?
?Yes
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11. Are the benefits worth the harms and costs?
Yes
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The frustrations of a bronchiolitis trial
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Bronchiolitis Research• Many studies/ meta analyses• Many definitions of bronchiolitis• Many age ranges• Many populations• Many confounding factors• Many outcomes (scores/ length of treatment/ length of
stay
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Definitions of BronchiolitisUK
• “a seasonal viral illness characterised by fever, nasal discharge, dry, wheezy cough”.
• On examination there are fine inspiratory crackles and/ or high pitched expiratory wheeze
• Infants under 1 year of age
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USA
“a constellation of of clinical symptoms and signs including a viral upper respiratory prodrome followed by increased
respiratory effort and wheezing in children less than 2 years”
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Diagnosis• Clinical• ?NPA• ?CXR
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Schuh et al, 2007 (J Pediatr)• 265 infants with simple bronchiolitis, all had CXR• Only 2 CXRs not consistent with bronchiolitis (& neither
case changed management)• More likely to treat with abx after reviewing CXRs
(although not indicated)
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Management
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Aetiology• Viral upper -> Lower
respiratory infection• Bronchiolar epithelial
inflammation• Peribronchial infiltration of
WBCs• Submucosal oedema• Airway narrowing through
oedema and blockage with mucus (not smoothe muscle constriction)
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Wheeze
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Bronchodilators
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Bronchodilators• 8 trials, 468 infants• No improvement in score in 43% treated with
bronchodilators (57% in controls)• Modest, short term effect in scores• No change in other clinical measures (eg oxygenation)• Authors conclude bronchodilators not recommended
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Authors’ Conclusions• Insufficient evidence to support use for inpatients.• Possibly some benefit as outpatients• Variety of definitions, outcomes and patient groups
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Inflammation
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Corticosteroids• Howard M et al, 2007• 600 infants 2-12 months• Randomised to dex or
placebo• No difference in scores,
admission rates, clinical outcomes
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? Benefit combined?
• Hartling et al 2011• Controversial meta-
analysis• Accused of selection bias• Included children up to 2
yrs
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Airway Oedema
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Hypertonic saline• Zhang et al, 2013• Hypertonic vs 0.9% saline • Infants <2 years• Conclude that length of
stay reduced by hypertonic saline
• But many confounding factors in studies analysed
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SABRE: Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation