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

Hargarten 1990.

Study characteristics
Methods Parallel‐design (2 arms)
Country: USA
Follow‐up: unclear
Participants Randomly assigned: N = 1427
  • Lidocaine group: 49.33% (704/1427)

  • Control group: 50.66% (723/1427)


Age, years, mean (standard error or standard deviation unclear) (total group)
  • Male: 62.1 (13.7)

  • Female: 67.5 (14.2)


Gender, male, % (n/N)
Total group: 50.17 (716/1427)
Inclusion criteria
  • ≥ 18 years of age

  • Chest pain of suspected cardiac origin


Exclusion criteria
  • Warning arrhythmias

  • Second‐ or third‐degree heart block

  • Bradycardia < 50

  • Hypotension < 90 mmHg

  • Known allergy to lidocaine

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
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
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)