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

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)
  • Lidocaine group: 51.49 (207/402)

  • Placebo (normal saline) group: 48.50 (195/402)


Age: 56 years (both groups); not reported by comparison groups
Gender, male, % (n/N)
  • Total group: 71.14 (286/402)

  • By comparison group: not reported


Inclusion criteria
  • Suspected acute myocardial infarction

  • Age < 70 years

  • Assessed within 6 hours of onset of symptoms


Exclusion criteria (≥ 1 of the following was present)
  • Heart rate ≤ 50 bpm

  • Heart rate ≥ 100 bpm after pain relief

  • Systolic blood pressure ≤ 80 mmHg after pain relief

  • Acute pulmonary oedema

  • Second‐degree or complete atrioventricular block

  • Sustained ventricular tachycardia

  • Ventricular fibrillation

  • Prior therapy with antiarrhythmic agents but excluding beta‐blockers or digoxin

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
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
  • Heart rate > 110 bpm before receipt of trial drug: 9

  • Taking oral antiarrhythmic (mexiletine, amiodarone) before the study: 7

  • Age > 70 years: 3

  • Delay in time > 6 hours: 1

  • Other reasons: 2


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)