Rossi 1976.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Italy Follow‐up period: 3 weeks | |
Participants | Randomly assigned: N = 246
Age, years: not reported Gender, male: not reported Inclusion criteria
Exclusion criteria
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Interventions | Lidocaine by an intramuscular injection of 250 mg Placebo: physiological solution and intervention in equal volumes Co‐intervention: not reported |
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Outcomes | Mortality Incidence of severe arrhythmias | |
Notes | Sample size calculation a priori: not reported
Sponsor: Astra Company
Role of sponsor: Lidocaine and saline solutions have been packaged for the double‐blind by Astra Company Trial conduction dates: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "and was randomised... " (page 221) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The contents of the syringe [are] kept secret until after the search. The distribution of the drug or placebo was randomised at the time of the package" (page 221) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information about the blinding level process to permit judgement of ‘low risk’ or ‘high risk’ |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The report gave the impression that no dropouts or withdrawals had occurred, but this was not specifically stated |
Selective reporting (reporting bias) | Low risk | All clinically relevant and reasonably expected outcomes were reported |
Other bias | High risk | Design bias (Porta 2008) Industry bias |