1. Paediatric Ambulatory Care 1
Produced 2010
Management of Croup
By Robin Hyde

2. Croup (Laryngotracheobronchitis)
Common childhood illness
Peak incidence 2yrs of age m:f ratio 1.5 : 1
Cause= Parainfluenza
Result upper airway obstruction
S/S Cough (Barking),Stridor,Hoarse,Fever
1 in 10 children require hospitalisation
Estimated costs $56 million in the US
Mortality rate low 1 in 10,000
Can be epidemic in the winter months
Wide classification Mild Moderate or Severe
Tools: Westley Croup Score or Modified Taussig Score Bjornson et al (2004) Knutson and Aring (2004) Patient UK (2009)

3. Clinical Question RATIONALE No UK Based Guidelines
Sporadic and Variable practice
Formulation of Question PICO format
P= infant,child, paed/paediatrics', croup, Laryngotracheobronchitis, mild, moderate
I = single oral dose dexamethasone
C= single oral dose prednisolone
O= efficacy of treatment, symptom relief, re-admission rate reduced
“In the infant over 3 months of age, presenting to the acute admission unit with mild-moderate croup, does a single dose of dexamethasone match in efficacy of treatment i.e. re-admission rate and symptom relief, compared to a single dose of prednisolone”?

4. SEARCH STRATEGY
INCLUSION criteria: - RCTs, articles in English, post 2000, infant/child >3 months, solely presenting croup with mild to moderate classification, A&E/AAU
EXCLUSION criteria: - non-English articles, pre 2000, infant/child with predisposing respiratory complication (asthma, CF), severe croup/PICU setting, recent systematic reviews (i.e. In the last 5 years), meta-analysis’
DATABASE use: -
TRIP database, Clinical evidence, Pubmed, Cochrane Library, Google Scholar
Medline , hits 8
Cinahl, hits 6
Embase, hits 6
BNI, Hits 0
2 Articles chosen to use

5. ARTICLES...
Prednisolone versus dexamethasone in croup: a randomised equivalence trial
Sparrow and Geelhoed (2006)
Comparison between single-dose oral Prednisolone and oral dexamethasone in the treatment of croup: a randomised, double blinded clinical trial
Fifoot and Ting (2007)

6. Appraisal? CASP tool format ( PHRU 2006)
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007)
-YES
-intervention clear
(oral pred vs dex)
-outcomes considered i.e. Primary Re-attendance rate, duration of stay
Use of adrenaline,
Duration of s/s
-Secondary croup score, adrenaline use, duration of croup, viral symptoms
-duration of time within ED
-Yes
(oral pred vs x2 doses of oral dex)
-Primary outcomes considered i.e. Reduced Westley croup score,
Secondary
rate of return
Further treatment of steroids in the week subsequent to presentation
-proportion of subjects requiring admission or salvage therapy
-population age groups stated 3mo-11yrs
-population age groups stated 6 mo-6yrs
Appraisal? CASP tool format ( PHRU 2006)
10 questions to make sense of Randomised Controlled Studies
QUESTION 1
Did the study ask a clearly-focused question?

7. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-comparison of a therapeutic intervention
10 questions to make sense of Randomised Controlled Studies
QUESTION 2
Was this a randomised controlled trial and was it appropriately so?

8. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-patients eligible if they had not received steroids
-classified mild>moderate croup (Taussig score)*
->3months
-groups well balanced
-133 children, 68 dex 0.15 mg/ kg and 65 pred 1mg/kg
-6mo-6yrs croup score 2 or more (Westley score)*
-available for telephone f/u 1wk
99 children, 34 pred , 34 dex 0.15mg/kg, 31 dex 0.6mg/kg
-excluded if severe croup
-excluded if families did not have a telephone (follow up)
-non-English speaking or limited
-excluded chronic resp disease+severe croup
excluded patients previously treated with steroid's, or nebulised adrenaline
-computer generalised randomisation
-informed consent obtained
-approved by hospital ethics committee
10 questions to make sense of Randomised Controlled Studies
QUESTION 3
Were participants appropriately allocated to intervention and control groups?
*please see Appendix 1

9. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-double blinded
-patients received either
0.15mg/kg dex
1mg/kg pred
-1 mg/kg pred
-0.15mg/kg dex
-0.6mg/kg dex
-bottles labelled A/B
-post randomisation, medication given by a nurse who took no further part in the child’s care
-study solutions flavoured to standardise taste and palatability
-steroid preps manufactured to ensure
-volume, taste and appearance exact same
-medical notes and drug charts recorded ‘trial medication’ and volume given to avoid bias
10 questions to make sense of Randomised Controlled Studies
QUESTION 4
Were participants, staff and study personnel ‘blind’ to participants study group?

10. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-all accounted
-133 followed up
States 87% were available for follow up
-table
-n=f/u
-n=re-attended
-n=admitted
-t=in department
-duration of s/s
-n=received rescue meds
-flow chart and tables
-n=who received what
-n=lost
-outcome measure in ED department
-outcome measures at 1 week f/u
10 questions to make sense of Randomised Controlled Studies
QUESTION 5
Were all of the participants who entered the trial accounted for at its conclusion?

11. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-follow up by telephone call in 1 week
10 questions to make sense of Randomised Controlled Studies
QUESTION 6
Were the participants in all groups followed up and data collected in the same way?

12. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
Yes
-X2 test was used for analysis of categorical variables
-student t test for analysis of continuous variables
-sample size calculations done on detecting a difference in the decrease of Westley croup score from baseline
-logarithmic transformation carried out for duration of hospital admission
-33 pts required per group
-mann-whitney u test
-x2 analysis
-p-values
-Expecting a re-attendance rate of 2% <less for an equivalence range between 0+7.5%
-108 pts were required to achieve a power of 90%
-(recruited 130+pts)
10 questions to make sense of Randomised Controlled Studies
QUESTION 7
Did the study have enough participants to minimise the play of chance?

13. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
-Results in a table
-percentages
Results in a table and graph form
-representation rate
-pred 19/65 (29%) re-attended
-dex 5/68 (7%) re-attended
-mean croup post administration
-dex 0.15mg/kg 2.09
-dex 0.6mg/kg 2.23
-pred 1mg/kg 2.35 p=
-CI around the 22% difference were 8>35% outside the 0-7.5% range of equivalence
P value=0.01
-greatest change in croup score 1h post
P=0.86
-re-presentations
17% pred
13+11% dex p=0.860
-Single oral dose of pred has proven less effective than dex in rate of re-attendance
-Little difference in efficacy between dex or pred in reducing the croup score
10 questions to make sense of Randomised Controlled Studies
QUESTION 8
How are the results presented and what is the main result?

14. 10 questions to make sense of Randomised Controlled Studies
Sparrow and Geelhoed (2006)
Fifoot and Ting (2007
QUESTION 9
-In depth analysis
-1 CI reported
-p values reported in less statistically important factors
-no CI
-p values useful
QUESTION 10
-Good range of outcomes considered
e.g. Nebulisation need
-admissions
-duration of croup symptoms
-study population similar
10 questions to make sense of Randomised Controlled Studies
QUESTION 9
How precise are these results?
QUESTION 10
Were all important outcomes considered so the results can be applied?

15. DISCUSSION and CONCLUSION
Can I answer my clinical question from this appraisal?
Inconclusive-there is some evidence to support that dexamethasone provides more efficient treatment than prednisolone but not enough to say conclusively
More research required
Primary care
Over a longer period
? Does multiple doses of corticosteroids provide improved efficacy in treatment than single doses?
APNP will be guided by local policy
Possibility of change locally
?NEED FOR SOME UK GUIDELINES

16. References
Appraisal tool for randomised controlled trials studies NHS Critical Appraisal Skills Programme (2006)
(accessed 20/08/2009)
Bjornson, C L Klassen, T P Williamson, J Brant , R Mitton C, Plint , A Bulloch, B Evered, L and Johnson, D (2004) A randomised trial of a single dose of oral dexamethasone for mild croup The New England Journal of Medicine 13 :
Fifoot, A and Ting, Y S (2007) Comparison between single-dose oral prednisolone and oral dexamethasone in the treatment of croup: a randomised double blinded clinical trial Emergency Medicine Australasia
Knutson, D and Aring, A (2004) Viral Croup American Family Physician
Johnston, D (2008) Croup Clinical Evidence
(accessed 04/12/09)
Patient Uk-Croup
accessed 17/11/09
Sparrow, A and Geelhoed, G (2006) Prednisolone versus dexamethasone in croup: a randomised equivalence trial Archives of Disease in Childhood
Westley CR, Ross EK, and Brooks JG. Nebulised racemic epinephrine by IPPB for the treatment of croup American Journal of Disease in the Child 1978;132:484–487
Westley Croup Score
(accessed 17/11/09)

17. Appendix 1 Westley Croup Score Modified Taussig Croup Score Stridor
Total score ranging from 0–17 points. Five component items make up the score:
• Stridor (0 = none, 1 = with agitation only, 2 = at rest)
• Retractions (0 = none, 1 = mild, 2 = moderate, 3 = severe)
• Cyanosis (0 = none, 4 = cyanosis with agitation, 5 = cyanosis at rest)
• Level of consciousness (0 = normal [including asleep], 5 = disorientated)
Mild= score 0-2
Moderate= score 3-5
Severe= score 6-11
Impending respiratory failure= score > 11
Modified Taussig Croup Score
Stridor
None 0
Only on crying, exertion 1
At rest 2
Severe (biphasic) 3
Retractions
*1-2 mild, 3-4 moderate, 5-6 severe
Westley et al (1978) Johnston (2008)