Hargarten 1990.
Study characteristics | ||
Methods | Parallel‐design (2 arms) Country: USA Follow‐up: unclear | |
Participants | Randomly assigned: N = 1427
Age, years, mean (standard error or standard deviation unclear) (total group)
Gender, male, % (n/N) Total group: 50.17 (716/1427) Inclusion criteria
Exclusion criteria
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Interventions | Lidocaine, intravenous (IV), initial bolus of 1 mg/kg; simultaneous 2 mg/min IV drip to maintain therapeutic blood levels. Ten minutes after first dose of lidocaine, second bolus of 0.5 mg/kg to prevent decrease to below therapeutic range Control group: not detailed Co‐intervention: not reported |
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Outcomes | Incidence of sudden death Incidence of warning arrhythmia | |
Notes | Sample size calculation a priori: not reported
Sponsor: not reported Trial conduction dates: January 1984 to January 1988 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "... was generated from a table of numbers from the Minitab software package of Perkin‐Elmer 3230 Supermini Computer" (page 82) |
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 to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information 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 | Bias in presentation data (Porta 2008) |