Lie 1978.

Study characteristics
Methods	Parallel design (2 arms) Country: The Netherlands Follow ‐up: 1 hour
Participants	Enrolled: 321 Randomly assigned: N = 300 Lidocaine group: 147 Control (sodium chloride 0.65% and water in deltoid muscle) group: 153 Age, years Lidocaine group: 58.8 Control (sodium chloride 0.65% and water in deltoid muscle) group: 57.1 Gender, male, % (n/N) Lidocaine group: 80.27 (118/147) Control (sodium chloride 0.65% and water in deltoid muscle) group: 74.4 (117/153) Inclusion criteria Patients < 70 years old within 6 hours of onset of symptoms of acute myocardial infarction History of chest pain correlated with typical electrocardiographic changes (new Q waves and loss of R wave voltage) Serial rise in serum enzyme values, creatine phosphokinase, glutamic oxalacetic transaminase and lactic dehydrogenase Exclusion criteria Patients with bradycardia with a ventricular rate < 50 beats/min Pulmonary congestion Complete atrioventricular block Persistent ventricular tachycardia or fibrillation
Interventions	Lidocaine group: lidocaine 300 mg intramuscular in a 10% solution Placebo: "sodium chloride 0.65 percent and water in the deltoid muscle..." (page 487)
Outcomes	Incidence of major ventricular arrhythmias Mortality
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	"...randomized patients received..." (page 487) 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	Low risk	Quote: "The nature of the injected solution was unknown to the medical and nursing staff" (page 487)
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	Withdrawls from the study Post randomisation: 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)