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. 2014 Jul 30;2014(7):CD003488. doi: 10.1002/14651858.CD003488.pub3
Methods Study design: randomized controlled trial
Study dates: 1987 to 1988
Diagnostics: viral isolation, serological diagnosis: haemagglutinin inhibition (HI) test, ELISA for dengue antibodies
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
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
Outcomes 1. Death
2. Number needing blood transfusion
3. Duration of hospitalization
4. Number getting complications (separate data for each complication)
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)
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