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. 2018 Aug 22;2018(8):CD001955. doi: 10.1002/14651858.CD001955.pub4

Kuusela 1988.

Methods Randomised double‐blind controlled trial
Participants Study period: October 1984 to March 1985 and January 1986 to April 1986
Setting: Department of Paediatrics, Tampere University Central Hospital, Finland
Inclusion criteria: children diagnosed and admitted for acute laryngitis (croup)
Exclusion criteria: not reported
Baseline demographics (N = 72):
proportion males: treatment 1: 74%; treatment 2: 88%; treatment 3: 88%; control: 67%
mean (SD) age in years: treatment 1: 2.9 (1.5); treatment 2: 2.3 (1.7); treatment 3: 2.8 (1.8); control: 3.2 (2.7)
croup score: not measured
Interventions All children received initial treatment in the emergency department, then were transferred to a ward where they were placed in a humid room and given oral fluids at a minimum of 20 mL/kg body weight over the next 4 hours.
Treatment 1 (N = 19): single 0.6 mg/kg (0.12 mL/kg, maximum 2 mL) dose of intramuscular dexamethasone plus at least 1 0.25 mL/5 kg (maximum 1.5 mL) dose of nebulised L‐epinephrine (2.25% epinephrine base with 0.5% chlorobutanol as preservative). Additional doses of nebulised L‐epinephrine every 2 hours as needed
Treatment 2 (N = 16): single 0.6 mg/kg (0.12 mL/kg, maximum 2 mL) dose of intramuscular dexamethasone plus at least 1 0.25 mL/5 kg (maximum 1.5 mL) dose of nebulised placebo solution. Additional doses of nebulised placebo every 2 hours as needed
Treatment 3 (N = 16): single 0.6 mg/kg (0.12 mL/kg, maximum 2 mL) dose of intramuscular placebo plus at least 1 0.25 mL/5 kg (maximum 1.5 mL) dose of nebulised L‐epinephrine (2.25% epinephrine base with 0.5% chlorobutanol as preservative). Additional doses of nebulised L‐epinephrine every 2 hours as needed
Control (N = 21): single 0.6 mg/kg (0.12 mL/kg, maximum 2 mL) dose of intramuscular placebo plus at least 1 0.25 mL/5 kg (maximum 1.5 mL) dose of nebulised placebo solution. Additional doses of nebulised placebo every 2 hours as needed
Outcomes Change in clinical score based on dyspnoea and cough scale from baseline to 6, 12, and 24 hours; length of stay in hospital
Notes Funding source: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information provided to judge.
Allocation concealment (selection bias) Low risk Quote: "the ampules were unlabelled, numbered, and randomized; the code was not available for investigators until the end of the study"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The placebo preparation consisted of the corresponding diluent supplied in similar ampules." "the code was not available for the investigators until the end of the study" "The active solution and the placebo preparation were identically packed in individual randomized vials containing 10 ml"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: no description of a third‐party outcome assessor. Carried over judgement from blinding of participants and personnel
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: did not use intention‐to‐treat analysis. 8% (N = 6) excluded due to protocol violations, unclear what group they were in.
Selective reporting (reporting bias) Unclear risk Comment: no protocol identified. All prespecified outcomes from methods appear in results.
Other bias Low risk Comment: no other sources of bias identified.
Overall risk of bias 
 All outcomes Unclear risk Comment: at least 1 domain judged as unclear risk, and no domains judged as high risk.