O'Brien 1973.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: New Zealand Follow‐up period: 48 hours | |
Participants | Randomly assigned: N = 300
Age: not reported Gender (male): not reported Inclusion criterion: proven myocardial infarction Exclusion criteria
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Interventions | Lidocaine, 75 mg, first bolus. Infusion 2.5 mg/min in 5% dextrose at 1 mL/min Placebo: 5% dextrose solution Co‐intervention: not reported | |
Outcomes | Reducing the frequent of ventricular fibrillation and ventricular tachycardia | |
Notes | Sample size calculation a priori: not reported Sponsor: not reported Trial conduction dates: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "allocation.... by means of random selection" (page 36) 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 | Unclear risk | Insufficient information about the blinding level process to permit judgement of ‘low risk’ or ‘high risk’ Comments: This was described as double blind |
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 | The study protocol is not available, but it is clear that published reports describe all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon) |
Other bias | High risk | Design bias (Porta 2008) |