| Methods |
Randomised, parallel, double‐blind comparison of rimantadine with acetaminophen
Study duration: 7 days
1 patient dropped out, due to AE
Co‐interventions and other potential confounders were not observed |
| Participants |
69 children were included, 40 females and 29 males
Inclusion criteria: clinical illness and viral isolation
Exclusion criteria: previously unhealthy aged 1 to 15 years
Disease stage: clinical illness and laboratory‐confirmed infection |
| Interventions |
Rimantadine: 6.6 mg/kg/d, max: 150 mg/d (< 9 years) and 200 mg/d (>= 9 years), 2 x/d; by oral route, for 5 days |
| Outcomes |
Mean symptom score of: fever, conjunctivitis, eye symptoms (pain on movement, fever up to 3rd day, conjunctivitis up to 3rd day, eyes symptoms (pain on movement and visual distortion); cough up to 7th day; malaise up to 6th day; CNS symptoms |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
It is stated in the published study that "Patients were assigned to the rimantadine or acetaminophen treatment group under a double‐blind, randomised allocation". The investigators also reported in their correspondence to the review authors that a computer random system was used to randomise participants |
| Allocation concealment (selection bias) |
Low risk |
Participants and investigators enrolling participants could not foresee assignment because a pharmaceutical‐controlled randomisation was used to conceal allocation, as stated in the authors' correspondence to the review authors |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1 "child receiving rimantadine complained of nausea and vomiting and withdrew from the study on the second day". The proportion of missing outcomes compared with observed event risk is not enough to have a clinically relevant impact on the intervention effect estimate |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Although "patients were assigned to the rimantadine or acetaminophen treatment group under a double‐blind, randomised allocation", the specific people who are blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Although "patients were assigned to the rimantadine or acetaminophen treatment group under a double‐blind, randomised allocation", the specific people who are blinded are not listed |
