Baker 1971.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: England Follow‐up period: 48 hours | |
Participants | Enrolled: 91 Randomly assigned: N = 44 (acute myocardial infarction within 48 hours before admission)
Age, % (n/N)
Gender, male, % (n/N)
Inclusion criterion: patients with acute myocardial infarction Exclusion criteria
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Interventions | Lidocaine: continuous infusion of 1.5 mg of lidocaine per minute in 5% dextrose solution Placebo: 5% dextrose solution: continuous infusion alone at same speed as intervention Co‐intervention: "additional lidocaine, either as bolus injection or as increased infusion doses, was given to four patients" (page 53) |
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Outcomes | Mortality Incidence and types of dysrhythmias | |
Notes | Sample size calculation a priori: not reported
Sponsor: not reported 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 | "...numbered according to a randomized sequence" (page 2) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | "... cards in sealed envelopes number ..." (page 2) Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | " a double‐blind trial" (page 1) Insufficient information about the blinding level process to permit judgement of ‘low risk’ or ‘high risk’ |
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 |
Other bias | High risk | Design bias (Porta 2008) |