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MedScape Pediatrics Viewpoints – Top Articles

from 2015 and 2016

William (Bill) Basco, MD, MS

Editor, MedScape Pediatrics Viewpoints

www.musckids.com

Disclosures:

• Neither Dr. Basco nor family members own financial interest in MedScape or parent companies

• Off-label uses of medications will be revealed if they are reviewed

• MUSC Dept of Pediatrics receives payment for Dr. Basco’s role at MedScape

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What is MedScape Viewpoints?

• Year 2000 - began as MedScape Journal Scan

• Year 2002 – Bill Basco became editor

• Year 2007 – evolved to MedScape Viewpoints

• Monthly summaries of articles of interest

• Chosen by Editor

• Circulation: 2000-80,000 page views per Viewpoint

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Outline:

• I. Review Widely-accessed Articles in MedScape Pediatric Viewpoints in either 2015 or 2016.

• II. Specific topics will include – Tdap effectiveness

– ADHD diagnosis

– Anaphylaxis

– Pertussis

– Skin and Soft Tissue infections

– Child abuse

– Asthma prevention with Vitamin D

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Year 2015 - #5

Pediatrics. 2015;136:635-641

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Sources of Infant Pertussis - Introduction

• Pertussis in US increasing since 2005

• Change to acellular vaccine associated with waning immunity (see later slides!)

• Research Question:

– What is the source of pertussis among cases where we can identify a source?

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Sources of Infant Pertussis - Method

• Data Source: Enhanced Pertussis Surveillance (EPS) system. Surveillance personnel contacted families to gather – demographic characteristics

– clinical presentation

– source of infection for the child

• Cases: Infants aged 1 year or younger with pertussis from 2006 to 2013

• Definition of case: – All met clinical definition based on symptoms

– “Confirmed cases” had clinical dx + isolation of B pertussis from culture

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Sources of Infant Pertussis - Results

• > 1300 children identified

• 24.2% of whom were < 2 months old

• 50.5% male; 74.2% were white, 28.9% were of Hispanic.

• 34% hospitalized

• 43.6% of CASES had IDENTIFIABLE SOURCE

– 35.5% siblings

– 20.6% mothers

– 10% fathers

– 7.6% grandparents

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Sources of Infant Pertussis - Results

• Represents an epidemiological shift

– Mothers were most common source for children born 2006-2007

– Siblings were primary for children born 2008 and thereafter

– Median age of siblings who provided the exposure: 8 years

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Sources of Infant Pertussis – Conclusions/Viewpoint

• Authors:

– Data suggest shift to siblings as source

– Current approach to vaccine pregnant moms and adult household contacts may miss the biggest “reservoir”

• Viewpoint:

– Uptake of Tdap among pregnant women, fathers of newborns, and older adolescents is low anyway – not sufficient

– Bad news – may get worse (see later study on waning Tdap immunity)

– Good news – still lots of work to do to improve delivery!

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Year 2015 - #4

J Pediatr. 2015;167:719.e.3-724.e.3

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Glucocorticoids and Anaphylaxis - Introduction

• Up to 20% of subjects who have anaphylaxis can have biphasic reaction

• Data to suggest routine use of glucocorticoids are lacking

• Research Question: Does administration of glucocorticoid to hospitalized patients with anaphylaxis improve outcomes?

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Glucocorticoids and Anaphylaxis - Method

• Subjects: > 10,000 children with anaphylaxis

• Ages: 1 month – 18 years

• Years: 2009-2013

• Data: administrative data to identify anaphylaxis

– Grouped by whether they received one of the following or not:

– dexamethasone, methylprednisone, prednisolone, or prednisone

– Collected from Pediatric Health Information System (35 hospitals in this study)

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Glucocorticoids and Anaphylaxis - Method

• Primary Outcome: “prolonged” LOS (≥ 2 days)

• Secondary Outcomes:

– repeat ED visit within 3 days

– Or required epinephrine after first 24 hours in hospital

• Additional variables evaluated/controlled for:

– Demographics

– Asthma

– Complex chronic conditions

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Glucocorticoids and Anaphylaxis - Results

• 5,203 hospitalized subjects

• Prolonged LOS in 8.2% of subjects

– Steroid receipt associated with lower odds of prolonged stay - adjusted OR 0.61 (95% CI 0.41-0.93)

• Other factors associated with greater odds of prolonged stay:

– chronic medical condition (aOR, 2.98)

– hx asthma (aOR, 1.56)

– Need for Oxygen (aOR, 2.52)

– admission to ICU (aOR, 13.4)

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Glucocorticoids and Anaphylaxis - Results

• Secondary Outcomes:

• Receipt of glucocorticoids associated with lower odds of needing epinephrine (aOR, 0.63)

• Receipt of glucocorticoids associated with no difference in odds of repeat ED visit (aOR 1.01, with a 95% CI that included 1.0)

– 4.9% had at least one ED visit within 3 days of the index visit.

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Glucocorticoids and Anaphylaxis – Conclusion/Viewpoint

• Authors:

– Receipt of glucocorticoid in the ED was associated with a lower odds of a prolonged hospital stay

– Findings support administration of glucocorticoid to ANY child admitted for anaphylaxis

• Viewpoint:

– Non-randomized data, but the biases should work AGAINST finding an effect (sicker kids get steroids)

– Mixed bag of drugs evaluated – no adjustment for dose

– Take home: At least not harmful to use, and probably beneficial

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Year 2015 - #3

J Pediatr. 2015;167:639-644

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Dexamethasone vs. Prednisone for Asthma - Introduction

• Dexamethasone has longer half-life, tastes better

• Need to do direct comparison of oral dex v oral prednisone

• Research Question: Which works better?

• Study type: comparative effectiveness

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Dexamethasone vs. Prednisone for Asthma - Method

• Subjects: 4-17 y.o. hospitalized 2007-2012

– Excluded ICU admits, chronic conditions, etc

• Analyses: compared outcomes between those who received oral dex vs. oral prednisone

• > 40,000 admissions (source: PHIS)

– 2.9% received dexamethasone; 97.1% prednisone

– Propensity-score matched on demographics and clinical variables

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Dexamethasone vs. Prednisone for Asthma - Results

Dexamethasone Prednisone P-value

Length of Stay ≤ 1 day

67.4% 59.5% 0.002

Length of Stay ≥ 3 days

6.7% 12% 0.002

Readmission at 7 days

0.3% 0.9% NS

Readmission at 30 days

1.1% 2% NS

Costs $200 higher 0.001

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Dexamethasone vs. Prednisone for Asthma – Conclusion/Viewpoint

• Authors:

– Dexamethasone can be considered appropriate therapy for noncomplicated asthma in children requiring hospital admission

• Viewpoint:

– Comparative effectiveness studies may be the closest we’ll ever get to answering a question such as this

– Doesn’t tell us ideal dose, frequency, or duration

– Take home: OK to use it, but still insufficient randomized data to show big differences

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Year 2015 – Number 1!

Natl Health Stat

Report. 2015;3:1-7

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Diagnosis of ADHD - Introduction

• 11% of US children have ADHD; prevalence increasing

• AAP Clin Practice Guideline exists for diagnostic criteria: Pediatrics. 2011;128:1007-1022

Natl Health Stat Report. 2015;3:1-7

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Diagnosis of ADHD - Method

• Data: 2014 National Center for Health Statistics

• Inclusion: “Yes,” to question about whether physician had dx child with ADHD

• Survey of Households, children 2-15 years

– Parent report of dx source, comorbidities, age of dx, medication and treatment received

• N = 2,976 children


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Diagnosis of ADHD - Results

• Median age diagnosis = 7 years

• However, 31% diagnosed BEFORE 6 years

• Only 24% diagnosed AFTER 9 years

• Family members were first to suspect diagnosis

• Who made dx? – Pediatricians = 39%

– Psychiatrists = 18%

– Other physicians = 14.1%

– Psychologists = 14%

– Neurologists = 5% Natl Health Stat Report. 2015;3:1-7

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Diagnosis of ADHD – Results (by age)


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Diagnosis of ADHD - Results

• 89.9% - dx made by behavior rating scales (parent report)

• 81.9% - clinicians obtained information from adults outside of immediate family

• 68% had neuropsychiatric testing

• 30% had neurological imaging or tests – All testing more likely in children < 6 years old


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Diagnosis of ADHD – Conclusion/Viewpoint

• Authors:

– Physicians, esp. pediatricians, confer most ADHD dx

– For 18%, no adults outside of family provide input as part of evaluation

• Viewpoint:

– Good that neuropsychiatric testing more likely with “young” diagnosis

– Limitation: parental report

– Take home: get more input (> 1 setting) AND do less laboratory or radiological testing!

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On to 2016…

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Year 2016 - #5

JAMA. 2016;315:362-370

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Prenatal Vitamin D and Asthma - Introduction

• This posting reviewed 2 studies

– Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing and Offspring by Age 3 Years: the VDAART Randomized Clinical Trial

• Litonjua et al. JAMA. 2016;315:362-370

– Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial

• Chawes et al. JAMA. 2016;315:353-361

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Prenatal Vitamin D and Asthma - Method

US Trial (Litonjua) Danish Trial (Chawes)

Population Pregnant, 18-39 years, all atopic or partner with atopic disease (n= 800 analyzed)

Pregnant, mean age 32 years, 25% with asthma (n=581 analyzed)

Sites 3

Method Double-blind, placebo controlled Active = 4000-IU Vit D/day Placebo = 400 IU Vit D/day

Double-blind, placebo controlled Active = 2800-IU Vit D/day Placebo = 400 IU Vit D/day

Outcome - Primary

Physician Dx of Asthma by 3 years old

“Persistent wheeze” – frequency, asthma sx, steroid use at 3 years

Outcome – Secondary

Did mom’s achieve adequate Vit D levels? (≥ 30 ng/mL)

Frequency of lung sx, URI frequency, LRTI frequency

Outcomes – other

Child develop eczema, allergies based on IgE levels

www.musckids.com

Prenatal Vitamin D and Asthma - Outcomes

US Trial (Litonjua) Danish Trial (Chawes)

Outcome - Primary

Physician Dx of Asthma by 3 years old - 24.3% of Intervention group - 30.4% of placebo; difference NS - Hazard Ratio for Dx Asthma 0.80 (95% CI 0.60-1.0; p NS)

Overall – 18% of children developed persistent wheeze - 16% of Intervention group - 20% of placebo (95% CI for Hazard Ratio 0.52-1.12; p NS)

Outcome – Secondary

Did mom’s achieve adequate Vit D levels? – Yes – 39.2% of intervention vs 26.8% of controls Dose-response noted (post-hoc)

Increasing maternal Vitamin D level associated with decreased risk of primary outcome – was significant

Outcomes – other

Eczema – 21-23% of groups (NS) IgE – no difference Any allergic sensitization = 50% both groups (NS)

Dx of Asthma - 12% intervention - 14% controls – p NS No diff in RTIs, allergies, etc

Date of download: 6/22/2016 Copyright © 2016 American Medical

Association. All rights reserved.

From: Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by

Age 3 Years: The VDAART Randomized Clinical Trial

JAMA. 2016;315(4):362-370. doi:10.1001/jama.2015.18589



From: Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the

Offspring: A Randomized Clinical Trial

JAMA. 2016;315(4):353-361. doi:10.1001/jama.2015.18318

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Prenatal Vitamin D and Asthma – Conclusion

• Authors – Litonjua (US trial)

– Successful in increasing maternal vitamin D levels in the women

– No difference in primary outcomes

• Authors – Chawes (Danish Trial)

– No difference in primary outcomes

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Prenatal Vitamin D and Asthma – Viewpoint

• Viewpoint

– DANG! This could have been

“HUUUGE!”

– No safety concerns identified

– US trial enrolled HR mothers – should have been able to show difference

– The dose-response findings are interesting and keep the “lid off of the coffin” of maternal Vit D supplementation and asthma prevention

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Year 2016 - #4

Pediatrics. 2015;136:831-838

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Testing for Abuse - Introduction

• Determining which children with injury are at risk for abuse is difficult

• Research Questions:

– Primary - Are specific injury types more or less likely to be associated with abuse?

– Secondary – What is the variation in practice in evaluation of injuries that might be associated with abuse?

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Testing for Abuse - Method

• Data source: 18 Children's Hospitals participating in Pediatric Health Information System (PHIS)

• Subjects: < 24 months old with 1 of 11 “putative injuries” – potential red flags for abuse (see injuries listed on next slide)

• Years: 2004-2011

Candidate Injury % With Abuse

Diagnosis, Mean

(Range)

% With Skeletal

Survey, Mean

(Range)

% With

Neuroimaging,

Mean (Range)

% With Hepatic

Transaminases,

Mean (Range)

Age

Rate of abuse diagnosis and SS completion for each putative sentinel injury.

Daniel M. Lindberg et al. Pediatrics 2015;136:831-838

©2015 by American Academy of Pediatrics

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Testing for Abuse - Outcomes

• Only 46% of visits by a child with at least one of the putative sentinel injuries resulted in a skeletal survey

• Only 3 injuries were associated with abuse in >20% of cases

– Rib fractures (56.1%)

– intracranial hemorrhages (26.3%)

– abdominal trauma (24.5%)

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Testing for Abuse – Conclusions/Viewpoint

• Authors:

– Several injury types are associated with abuse > 20% of the time

– Further work needed to systematize the evaluation of patients with putative sentinel injuries

• Viewpoint: – Take home: Hard to argue with the top 3! Don’t be a contributor to

“variation” in workup of those 3!

– Also hard to know where to draw the lower-limit line? What % chance is “low enough” to skip evaluation for abuse?

– Figures DO NOT represent true incidence because not all children received full workup

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Testing for Abuse - Resources

• Evaluating Children With Fractures for Child Physical Abuse - Feb 2014 http://pediatrics.aappublications.org/content/133/2/e477.full

• The Evaluation of Suspected Child Physical Abuse – May 2015 http://pediatrics.aappublications.org/content/135/5/e1337.full

• Even more at: https://www2.aap.org/sections/childabuseneglect/policies.cfm

http://pediatrics.aappublications.org/content/133/2/e477.fullhttp://pediatrics.aappublications.org/content/133/2/e477.fullhttp://pediatrics.aappublications.org/content/133/2/e477.fullhttp://pediatrics.aappublications.org/content/135/5/e1337.fullhttp://pediatrics.aappublications.org/content/135/5/e1337.fullhttp://pediatrics.aappublications.org/content/135/5/e1337.full

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Testing for Abuse – Pearls from AAP Guidelines

• Physical abuse is in the differential diagnosis for children with fractures in the following situations:

– Fracture(s) in nonambulatory infants

– Children with multiple fractures;

– Infants and children with rib fractures;

– Infants and toddlers with midshaft humerus or femur fractures;

– Infants and children with unusual fractures, including those of the scapula, classic metaphyseal lesions (CMLs) of the long bones, vertebrae, and sternum

– The history of trauma does not explain the resultant fracture.

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Testing for Abuse – Pearls from AAP Guidelines

• The mnemonic “TEN 4” is an easy way to identify bruises that are of concern for abuse:

– T: torso;

– E: ear;

– N: neck; and

– 4: in children less than or equal to 4 years of age and in ANY infant under 4 months of age.

• Public service announcement – remember the FOLLOW UP Skeletal survey 2 weeks later!

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Year 2016 - #3

Pediatrics. 2016;137:1-9

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Waning Tdap - Introduction

• 1990’s – shift from whole-cell to acellular pertussis vaccines

• 2006 – recommendation for Tdap booster at age 10

• Research Question: Does Tdap protect adolescents and for how long?

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Waning Tdap - Method

• Study population: Kaiser Permanente of Northern California

• Years: 2010-2014, encompassing 2 outbreaks

• Primary Outcome:

– Vaccine effectiveness, by year, after receipt of Tdap

• Case definition: positive pertussis PCR

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Waning Tdap - Results

• N = 1207 cases among > 279,000 adolescents

• Infants always bear brunt of outbreaks

• 2010 epidemic – second peak at 10-11 years old

• 2014 epidemic – second peak at 15 years old

• Vaccine effectiveness (overall) = 68.8%

• Year 2 Vaccine effectiveness = 56.9%



Annual pertussis incidence, Tdap vaccination rate, and DTaP history in the KPNC population,

by age, during the pertussis outbreak from April 2014 to March 2015.

Nicola P. Klein et al. Pediatrics doi:10.1542/peds.2015-3326

©2016 by American Academy of Pediatrics

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Waning Tdap – Conclusions/Viewpoint

• Authors:

– Tdap provides only moderate protection in Year 1

– Protection wanes rapidly thereafter (35% annually)

– Question whether routine Tdap boost is worth it except in outbreaks!

• Viewpoint:

– This plus other studies show that the aging “acellular-only” cohort have rapidly-fading immunity before AND NOW AFTER the booster dose at 10 years

– Active area of investigation – stay tuned!

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Year 2016 - #1 so far…

JAMA. 2015;314:2034-2044.

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Azithromycin and Severe LRTI - Introduction

• 14-26% of preschoolers have recurrent wheezing episodes

• Suggestion that macrolides reduce neutrophilic inflammation

• Research Question: Does early administration of azithromycin during a RTI, before the onset of lower respiratory tract symptoms, prevent the progression of preschool wheezing?

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Azithromycin and Severe LRTI - Method

• Study: randomized, double-blind, placebo-controlled, parallel-group trial

• Source: 9 academic US medical centers in the National Heart, Lung, and Blood Institute’s AsthmaNet network

• Subjects: – 12-71 months old

– History of recurrent severe wheezing during RTIs (required steroids, emergent office or ED visits, or hospitalized)

• Exclusions: – > 4 courses of steroids in 12 months

– > 1 hospitalization in 12 months

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Azithromycin and Severe LRTI - Results

• Intervention:

– Azithro at standard doses (5 days) vs placebo

– Parents had drug at home – administered with onset of RTI symptoms

– Could receive albuterol as needed

• Primary Outcome:

– Number of RTIs that DID NOT PROGRESS to SEVERE LRTIs

– OR – systemic steroids; or withdrawal from study

– “Severe” – defined as: > “mild” symptoms after 3 albuterol treatments in 1 hour; albuterol > q 4 hours; > 6 albuterol treatments in 24-hours; “moderate or severe” cough 5 or more days after starting study medication

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• 607 children randomly assigned

– 27% -no RTIs, equal between treatment groups

– 39% had allergic sensitization to at least one allergen

– 47% considered “high risk” for later asthma

• Secondary outcomes (albuterol use, ED visits, hospitalization) NOT different



From: Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in

Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial

JAMA. 2015;314(19):2034-2044. doi:10.1001/jama.2015.13896

Cumulative Risk of Experiencing an Episode of Severe LRTI Across Treated RTIs for Preschool Children With a History of Severe

LRTIRTI indicates respiratory tract illness; SLRTI, severe lower RTI. Shown are risks and 95% CIs based on the discrete-time

proportional hazards model of treatment effect adjusted for clinical site, age, modified Asthma Predictive Index status, season during

which the treated RTI occurred, and whether the child enrolled before or after the study was extended to 78 weeks.

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• Overall hazard ratio of 0.64 (95% confidence intervals, 0.41-0.98).

• NNT = 33 for the first RTI to prevent one case of progression to severe LRTI

• NNT = 7 by the fourth RTI to prevent one case of progression to severe LRTI

• > 80% of subjects had at least 1 virus for RTI

• Azithromycin resistance increased

– 16.7% in treatment group

– 10.8 % in placebo group

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Azithromycin and Severe LRTI – Conclusion/Viewpoint

• Authors:

– azithromycin, when begun at the earliest symptoms of an RTI among children prone to wheezing, significantly reduced the chances of progression to severe LRTI

• Viewpoint (and Editorial):

– Benefit appears to be antimicrobial + anti-inflammatory

– NOT ready for “prime time” • Narrow inclusion criteria

• Not sure it would help ALL subjects with RTIs – these children had all wheezed before

• Study did NOT include infants; would not apply to children already meeting “Severe LRTI” criteria; 60% increase in resistant bacteria

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Year 2015 – Public Service Announcement!

N Engl J Med. 2015;373:2642-2653

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Public Service Announcement!

Do Not Recommend Home Birth! (unless you or your patients are gamblers)

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Association between Planned Out-of-Hospital Birth and a Composite Neonatal Outcome and Cesarean Delivery,

According to Subgroups.

Snowden JM et al. N Engl

J Med 2015;373:2642-

2653

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Out of Hospital Birth and Outcomes – Conclusion/Viewpoint

• Authors: – Planned out-of-hospital birth was associated with a

higher risk of perinatal death than that with planned

hospital birth, but mortality was low in both settings

and absolute differences were small.

• Viewpoint: – Studies repeatedly show the increased risk of home

birth despite ALL biases that exist FAVORING home

birth

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Sign up for Viewpoint:

• Not already Registered for Medscape:

– Register on Medscape as a user

– Presented with a screen to sign up for newsletters

– Sign up for the “pediatrics newsletters” • Viewpoints are always included as a Top 5 in those mailers.

• Already Registered, don’t get Viewpoints:

– Sign into Medscape

– Click on the gear symbol next to their name, to go My Accounts link.

– Will take you to a screen to both subscribe and unsubscribe from newsletters

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EXTRA if Time Allows

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Year 2015 - #11

N Engl J Med.

2015;372:1093-1103

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Clindamycin Vs Sulfa/TMX for SSTI- Introduction

• SSTI = “Skin and Soft Tissue Infections”

• You know the background of this – what a pain!

• Research question: Which does better?

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Clindamycin Vs Sulfa/TMX for SSTI- Method

• Subjects: 1:1 randomization to 2 drugs

– Seen at urgent care facilities 2009-2011, 4 cities

– Cellulitis or abscess, dx < 24 hours prior to enrollment

– Excluded: animal bites, oral temp > 101.3°F, immunosuppressed, other chronic conditions

– All had affected areas > 5 cm; all abscesses drained

• Primary outcome = “treatment failure,” defined as

– Active lesion at 7-10 d follow up; discontinuation ≤ 48 hours because of side effects; new body site infection; further surgical treatment required; hospitalization

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Clindamycin Vs Sulfa/TMX for SSTI- Results

• 524 randomized, approx. equal groups

• Sites

– Abscesses = 30.5%

– Cellulitis = 53.4%

– Both = 15.6%

• 93.5% of cultures were positive (56.5% cultured)

– 78% Staphylococcus aureus (77% of those were MRSA)

– 12.4% resistance to clindamycin

– 0.5% resistance to TMP-SMX

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Clindamycin Vs Sulfa/TMX for SSTI- Results

• Primary Outcome: 7-10 d Failure rate – no diff.

– Clindamycin = 20% failure rate

– Sulfa/TMX = 22.3% failure rate

• No differences in subgroup analyses

– Whether by cellulitis vs abscess

– Whether by “per protocol” – patients who adhered to treatment

• Secondary Outcomes: 1-month follow-up

– No differences in failure rates, both were higher

– Approx 18% of BOTH groups experienced side effects

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Clindamycin Vs Sulfa/TMX for SSTI- Conclusion/Viewpoint

• Authors:

– No significant differences in treatment outcomes

– Similar side effects

• Viewpoint:

– Both this trial and previous observational analysis (Pediatrics 2011;127: e573–e580) showed that antibiotic choice seemed to matter little after abscesses were drained

– The take-home point from 2011 still holds: Drain if you can, and antibiotic choice may not matter as much thereafter

– Generally holds that MRSA less prevalent in cellulitis only

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