Morikawa 1994(1).
Study characteristics | ||
Methods | Unit of randomisation: child
Method of randomisation: centralised
Timing of randomisation: time of diagnosis Blinding: yes (triple)
Power calculation: yes (80% with 150 in each group)
Number of centres: 95 313 patients randomised 2 exclusions from the adverse effects analysis, 11 from the CAA analysis and 11 from the duration of fever analysis 311 patients analysed for the adverse effects outcome, 299 patients analysed for the CAA outcome and 299 patients were analysed for the fever duration outcome Source of funding: not stated |
|
Participants | Children within 9 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: less than 6 years old Location: Japan Timing and duration: 1991‐1993 |
|
Interventions | 200 mg/kg/day of polyethyleneglycol‐treated human immunoglobulin
VS
400 mg/kg/day of IV polyethyleneglycol‐treated human immunoglobulin Duration: 5 days |
|
Outcomes | Coronary artery abnormalities Adverse effects Duration of fever | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |