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Table A Characteristics of randomised controlled trials of treatments for croup included in the meta-analysis
|
Trial |
No of patients |
Setting |
Intervention |
Control |
Outcomes |
Jadad score * |
Allocation Concealment † |
|
Cruz 1995w1 |
45 |
Accident and emergency |
Intramuscular dexamethasone 0.6 mg/kg |
Placebo |
Clinical improvement, visits to the doctor, readmissions |
2 |
1 |
|
Eden 1964w2 |
50 |
Hospital |
Intramuscular methylprednisolone 4 mg/kg/day |
Placebo |
Clinical improvement, use of mist tent and antibiotics |
3 |
3 |
|
Eden 1967w3 |
50 |
Hospital |
Intramuscular dexamethasone 0.4 mg/kg/day |
Placebo |
Stridor, dyspnoea, retractions, and cyanosis |
3 |
3 |
|
Fitzgerald 1996w4 |
67 |
Hospital |
Nebulised budesonide 2 mg |
L-epinephrine 4 mg |
Modified Westley croup score, use of epinephrine and steroids, length of hospital stay |
3 |
2 |
|
Geelhoed 1995w5 |
80 |
Accident and emergency |
Nebulised budesonide 2 mg Oral dexamethasone 0.6 mg/kg |
Placebo |
Stridor and retractions, use of epinephrine, length of stay in observation unit |
3 |
3 |
|
Geelhoed 1995aw6 |
60 |
Accident and emergency |
Oral dexamethasone 0.6 mg/kg |
Oral dexamethasone 0.3 mg/kg |
Stridor and retractions, use of epinephrine, length of stay in observation unit |
3 |
3 |
|
Geelhoed 1995bw6 |
60 |
Accident and emergency |
Oral dexamethasone 0.3 mg/kg |
Oral dexamethasone 0.15 mg/kg |
Proportion hospitalised in 24 hours |
|
|
|
Geelhoed 1996w7 |
100 |
Accident and emergency |
Oral dexamethasone 0.15 mg/kg |
Placebo |
Return to accident and emergency department for symptoms of croup |
2 |
3 |
|
Godden 1997w8 |
87 |
Hospital |
Nebulised budesonide 2 mg initially, then 1 mg every 12 hours during hospitalization |
Placebo |
Modified Westley croup score, use of epinephrine and intubation, length of stay |
4 |
3 |
|
Husby 1993w9 |
37 |
Hospital |
Nebulised budesonide 1mg/dose for two doses 30 minutes apart |
Placebo |
Modified Westley croup score, use of antibiotics |
3 |
3 |
|
James 1969w10 |
88 |
Hospital |
Intramuscular dexamethasone 4 -12 mg |
Placebo |
Use of mist tent or antibiotics, tracheostomy |
4 |
3 |
|
Johnson 1996w11 |
55 |
Accident and emergency |
Nebulised dexamethasone 10-20 mg |
Placebo |
Modified Westley croup score, admission rate |
4 |
1 |
|
Johnson 1998w12 |
144 |
Accident and emergency |
Nebulised budesonide 4 mg |
Placebo |
Westley croup score, use of epinephrine and mist treatment |
2 |
1 |
|
Klassen 1998w13 |
198 |
Accident and emergency |
Nebulised budesonide 2 mg Nebulised budesonide 2 mg and oral dexamethasone 0.6 mg/kg |
Oral dexamethasone 0.6 mg/kg |
Westley croup score, use of epinephrine and steroids, length of stay, admission rates |
5 |
1 |
|
Klassen 1994w14 |
54 |
Accident and emergency |
Nebulised budesonide 2 mg |
Placebo |
Westley croup score, use of epinephrine and steroids, length of stay, admission rates |
5 |
1 |
|
Klassen 1996w15 |
50 |
Accident and emergency |
Nebulised budesonide 2 mg and oral dexamethasone 0.6 mg/kg |
Oral dexamethasone 0.6 mg/kg |
Westley croup score, use of epinephrine and steroids, length of stay, admission rates |
5 |
1 |
|
Koren 1983w16 |
78 |
Hospital |
Intramuscular dexamethasone 0.6 mg/kg |
Placebo |
Respiratory rate |
2 |
3 |
|
Kuusela 1988w17 |
72 |
Hospital |
Intramuscular dexamethasone 0.6 mg/kg, Intramuscular dexamethasone 0.6 mg/kg, and L-epinephrine 2.25% 0.25 ml/kg |
L-epinephrine 2.25% 0.25 ml/kg |
Dyspnoea and cough, length of stay |
3 |
1 |
|
Leipzig 1979w18 |
30 |
Hospital |
Intramuscular dexamethasone 0.3 mg/kg/dose for two doses |
Placebo |
Stridor, cyanosis, retractions, respiratory rate, heart rate Use of epinephrine and intubation Length of stay |
3 |
3 |
|
Martinez 1993w19 |
66 |
Hospital |
L-epinephrine, L-epinephrine and intramuscular dexamethasone 0.5 mg/kg, intramuscular dexamethasone 0.5 mg/kg |
Placebo |
Stridor, dyspnoea, cough, cyanosis, use of mist treatment |
3 |
1 |
|
Massicotte 1973w20 |
42 |
Hospital |
Intravenous methylprednisolone 4 mg at 0, 4, and 8 hours |
Placebo |
Clinical improvement, use of antibiotics and tracheostomy |
4 |
1 |
|
Muhlendahl 1982w21 |
406 |
Hospital |
Oral dexamethasone 6 mg |
Placebo |
Westley croup score, clinical improvement, tracheostomy, length of stay |
2 |
3 |
|
Skowron 1966w22 |
200 |
Hospital |
Subcutaneous dexamethasone 4 or 6 mg |
Placebo |
Use of mist treatment, antibiotics, tracheostomy |
2 |
3 |
|
Super 1989w23 |
29 |
Hospital |
Intramuscular dexamethasone 0.6 mg/kg |
Placebo |
Westley croup score, clinical improvement, use of epinephrine, steroids, mist treatment, length of stay |
5 |
1 |
|
Tibballs 1992w24 |
73 |
Intensive care unit (intubated patients) |
Nasogastric prednisolone 2 mg/kg/day until 24 hours after extubation |
Placebo |
Length of intubation reintubation rate |
4 |
1 |
*Five point scale.
†Scored as 1=adequate, 2=inadequate, 3=unclear.
References:
w1 Cruz MN, Stewart G, Rosenberg N. Use of dexamethasone in the outpatient management of acute laryngotracheitis. Pediatrics 1995;96:220-3.
w2 Eden AN, Larkin VP. Corticosteroid treatment of croup. Pediatrics 1964;33:768-9.
w3 Eden AN, Kaufman A, Yu R. Corticosteroids and croup: controlled double-blind study. JAMA 1967;200:403-4.
w4 Fitzgerald D, Mellis C, Johnson M, Allen H, Cooper P, Van Asperen P. Nebulized budesonide is as effective as nebulized adrenaline in moderately severe croup. Pediatrics 1996;97:722-5.
w5 Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol 1995;20:355-61.
w6 Geelhoed GC, Macdonald WB. Oral dexamethasone in the treatment of croup: 0.15 mg/kg versus 0.3 mg/kg versus 0.6 mg/kg. Pediatr Pulmonol 1995;20:362-8.
w7 Geelhoed GC, Turner J, Macdonald WB. Efficacy of a small single dose of oral dexamethasone for outpatient croup: a double blind placebo controlled clinical trial. BMJ 1996;313:140-2.
w8 Godden CW, Campbell MJ, Hussey M, Cogswell JJ. Double blind placebo controlled trial of nebulised budesonide for croup. Arch Dis Child 1997;76:155-8.
w9 Husby S, Agertoft L, Mortensen S, Pedersen S. Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study. Arch Dis Child 1993;68:352-5.
w10 James JA. Dexamethasone in croup: a controlled study. Am J Dis Child 1969;117:511-6.
w11 Johnson DW, Schuh S, Koren G, Jaffe DM. Outpatient treatment of croup with nebulized dexamethasone. Arch Pediatr Adolesc Med 1996;150:349-55.
w12 Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med 1998;339:498-503.
w13 Klassen TP, Craig WR, Moher D, Osmond MH, Pasterkamp H, Sutcliffe T, et al. Nebulized budesonide and oral dexamethasone for treatment of croup: a randomized controlled trial. JAMA 1998;279:1629-32.
w14 Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med 1994;331:285-9.
w15 Klassen TP, Watters LK, Feldman ME, Sutcliffe T, Rowe PC. The efficacy of budesonide in dexamethasone-treated outpatients with croup. Pediatrics 1996;97:463-6.
w16 Koren GF. Corticosteroid treatment of laryngotracheitis v spasmodic croup in children. Am J Dis Child 1983;137:941-44.
w17 Kuusela AL, Vesikari T. A randomized double-blind, placebo-controlled trial of dexamethasone and racemic epinephrine in the treatment of croup. Acta Paediatr Scand 1988;77:99-104.
w18 Leipzig B, Oski FA, Cummings CW, Stockman JA, Swender P. A prospective randomized study to determine the efficacy of steroids in treatment of croup. J Pediatr 1979;94:194-6.
w19 Martinez Fernandez A, Sanchez Gonzalez E, Rica Etxebarria I, Echaniz Urcelay I, Alonso Diez M, Vilella Ciriza M, et al. [Randomized double-blind study of treatment of croup with adrenaline and/or dexamethasone in children]. Anales Españoles de Pediatría 1993;38:29-32. (In Spanish.)
w20 Massicote P, Tetreault L. [Evaluation of methyl-prednisolone in the treatment of acute laryngitis in children]. Union Med Can 1973;102:2064-72. (In French.)
w21 Von Muhlendahl KE, Kahn D, Spohr HL, Dressler F. Steroid treatment in pseudo-croup. Helv Paediatr Acta 1982;37:431-6.
w22 Skowron PN, Turner JA, McNaughton GA. The use of corticosteroid (dexamethasone) in the treatment of acute laryngotracheitis. Can Med Assoc J 1966;94:528-31.
w23 Super DM, Cartelli NA, Brooks LJ, Lembo RM, Kumar ML. A prospective randomized double-blind study to evaluate the effect of dexamethasone in acute laryngotracheitis. J Pediatr 1989;115:323-9.
w24 Tibballs J, Shann FA, Landau LI. Placebo-controlled trial of prednisolone in children intubated for croup. Lancet 1992;340:745-8.