Dunn 1985.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Northern Ireland Follow‐up period: not reported | |
Participants | Randomly assigned: N = 425 Withdrawal from study: 7.3% (31/425) Eight participants who had a proved myocardial infarction did not enter the study (page 354). Twenty‐three patients did not fulfil entry criteria Analysed, % (n/N)
Age: 56 years (both groups); not reported by comparison groups Gender, male, % (n/N)
Inclusion criteria
Exclusion criteria (≥ 1 of the following was present)
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Interventions | Lidocaine, 300 mg, intramuscular route, followed by lidocaine, 100 mg, by intravenous bolus over 3 minutes Placebo: normal saline (equivalent volume of normal saline) | |
Outcomes | Incidence of ventricular fibrillation, sustained ventricular tachycardia, warning arrhythmias Incidence of central nervous system side effects, hypotension, tachycardia, bradycardia, asystole | |
Notes | Sample size calculation a priori: not reported
Sponsor: not reported Trial conduction dates: November 1981 to February 1983 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | " ...we undertook a double‐blind randomised trial..." (page 354) 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 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 | Low risk | Withdrawals from study: 7.3% (31/425) Eight patients who had a proved myocardial infarction did not enter the study (page 354) Twenty‐three patients did not fulfil entry criteria
Comment: Trial authors did not report lost participants by comparison group |
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 of presentation data, design bias (Porta 2008) |