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

Wyse 1988.

Study characteristics
Methods Parallel design (2 arms)
Country: Canada
Follow‐up period: 24 hours
Participants Randomly assigned: N = 333
  • Lidocaine group: 49% (165/333)

  • Control group: 50.4% (168/333)


Age, years, mean (standard error)
  • Participants with myocardial infarction

    • Selective lidocaine strategy: 57 (1)

    • Prophylactic lidocaine strategy: 56 (1)


Gender, male, %
  • Selective group: 75

  • Prophylactic group: 77


Inclusion criteria
  • Proven myocardial infarction defined as

    • 6 hours of chest  pain

    • Typical Q waves and evolutionary ST‐T changes on electrocardiogram

    • Serial increase in serum creatine kinase (total or MB fraction or both)


Excluded criteria
  • > 75 years old

  • Complex ventricular arrhythmia requiring treatment on arrival

  • Advance heart failure or shock

  • Contraindication to lidocaine such as persistent sinus bradycardia (< 45 beats/min)

  • Liver disease

  • Allergy

  • Had received antiarrhythmic drugs in the previous 24 hours

  • Refused consent

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
  • Lidocaine group: 4% (1/26)

  • Placebo group: 4% (1/28)


Reasons
  • Atrial fibrillation

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)