Methods | Study design: randomized controlled trial Study dates: 1987 to 1988 Diagnostics: viral isolation, serological diagnosis: haemagglutinin inhibition (HI) test, ELISA for dengue antibodies |
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Participants | Number of participants: randomized: 63 enrolled (32 in corticosteroid
group; 31 in placebo group) Age: 3 to 14 years Inclusion criteria: children diagnosed with dengue shock syndrome using World Health Organization clinical criteria and serological confirmation Exclusions: not specified |
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Interventions | 1. Methylprednisolone (Solumedrol, Upjohn): single intravenous dose of 30
mg/kg in addition to fluid replacement 2. Placebo: 5% dextrose in normal saline solution |
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Outcomes | 1. Death 2. Number needing blood transfusion 3. Duration of hospitalization 4. Number getting complications (separate data for each complication) |
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Notes | Location: Khon Kaen University Hospital, and Khon Kaen Provincial Hospital
in Khon Kaen, Thailand Transmission: not specified Funding: Rockefeller Foundation (grant RF 87006#95) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Block randomisation" and "Generation of allocation sequence: generated by statistician and running number put on drug package" |
Allocation concealment (selection bias) | Low risk | Email correspondence with author: "By using sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Double blind", "All specimens were identified only by code number" and "identical placebo" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Email reply from author: outcome assessors was blinded to the intervention, they "knew patients by code number" only |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up were reported |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Low risk | No other bias identified |