Wyse 1988.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Canada Follow‐up period: 24 hours | |
Participants | Randomly assigned: N = 333
Age, years, mean (standard error)
Gender, male, %
Inclusion criteria
Excluded criteria
|
|
Interventions | Lidocaine: 100 mg intravenous loading infusion given over 3 to 5 minutes, followed by 3 mg/min continuous intravenous maintenance. An identical 100 mg intravenous infusion was administered 30 minutes after the first loading infusion. Dosage was adjusted on a milligram‐per‐kilogram basis for participants < 50 kg or > 90 kg Control: no information given about this issue | |
Outcomes | Safety of lidocaine therapy in participants with acute myocardial infarction | |
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 | "On randomization, drug (placebo or lidocaine) was administered..." (page 508) Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Insufficient information about the allocation concealment process to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "...(placebo or lidocaine) was administered in a double blind manner" (page 508) 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 | Dropout from the study
Reasons
|
Selective reporting (reporting bias) | High risk | One or more outcomes of interest in the review are reported incompletely, so they cannot be entered into a meta‐analysis "in mortality rate (selective=3%, prophylactic=5%, p=NS)" (page 507) This trial reported results by approach (prophylaxis vs selective) rather than by lidocaine vs placebo |
Other bias | High risk | Design bias and bias in data presentation (Porta 2008) |