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. 2015 Aug 21;2015(8):CD008553. doi: 10.1002/14651858.CD008553.pub2

Rossi 1976.

Study characteristics
Methods Parallel design (2 arms)
Country: Italy
Follow‐up period: 3 weeks
Participants Randomly assigned: N = 246
  • Lidocaine group: 40.24% (99/246)

  • Control (physiological solution and intervention in equal volumes) group: 59.7% (147/246)


Age, years: not reported
Gender, male: not reported
Inclusion criteria
  • Age < 70 years

  • Sudden chest pain, started no more than 8 hours earlier, lasted longer than 10 minutes, nitroglycerin‐resistant and not affected by respiratory movements


Exclusion criteria
  • Hypotension

  • Bradycardia

  • Arrhythmia that requires immediate treatment

Interventions Lidocaine by an intramuscular injection of 250 mg
Placebo: physiological solution and intervention in equal volumes
Co‐intervention: not reported
Outcomes Mortality
Incidence of severe arrhythmias
Notes Sample size calculation a priori: not reported
Sponsor: Astra Company
Role of sponsor: Lidocaine and saline solutions have been packaged for the double‐blind by Astra Company
Trial conduction dates: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "and was randomised... " (page 221)
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 Low risk "The contents of the syringe [are] kept secret until after the search. The distribution of the drug or placebo was randomised at the time of the package" (page 221)
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 All clinically relevant and reasonably expected outcomes were reported
Other bias High risk Design bias (Porta 2008)
Industry bias