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

Pitt 1971.

Study characteristics
Methods Parallel design (2 arms)
Country: Australia.
Follow‐up: 48 hours
Participants Randomly assigned: N = 222
Class 1 (participants without haemodynamic disturbances): 113

  • Lidocaine group: 54

  • Placebo (dextrose 5% by intravenous infusion) group: 59


Class 2 (hypotension blood pressure < 90 mmHg after relief of pain, or left ventricular failure): 109

  • Lidocaine group: 54

  • Placebo (dextrose 5% by intravenous infusion) group: 55


Age, years (range)
Class 1

  • Lidocaine group: 52 (27 to 69)

  • Placebo (dextrose 5% by  intravenous infusion) group: 56 (30 to 80)


Class 2

  • Lidocaine group: 58 (43 to 74)

  • Placebo (dextrose 5% by  intravenous infusion) group: 58 (33 to 77)


Gender, male, % (n/N)
Class 1

  • Lidocaine group: 92.59 (50/54)

  • Placebo (dextrose 5% by intravenous infusion) group: 94.9 (56/59)


Class 2

  • Lidocaine group: 87 (47/54)

  • Placebo (dextrose 5% by intravenous infusion) group: 89 (49/55)


Inclusion criteria: not reported
Exclusion criteria

  • 24 hours elapsed since onset of symptoms

  • Ventricular tachyarrhythmia

  • Third‐degree heart block
Interventions Lidocaine: 2.5 mg/min for 48 hours in 5% dextrose
For the first half of the trial, all participants receiving lidocaine were given an intravenous bolus injection of 75 to 100 mg, but this was not routinely administered in the second half of the trial
Placebo: dextrose 5% by intravenous infusion
Co‐interventions: pacemaker and lidocaine in control group because of the development of ventricular tachyarrhythmia
Outcomes Mortality
Fequency of ventricular tachyarrhythmia
Notes Sample size calculation a priori: no
Sponsor: Astra Chemicals Pty. Ltd.
Rol of the sponsor: not reported
Trial conduction dates: 5 January 1968 to 30 June 1970
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly allotted..." (page 613)
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 about the blinding level process to permit judgement of ‘low risk’ or ‘high risk’
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 "165 patients were excluded..." (page 613)
It is unclear whether these exclusions occurred before or after randomisation
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)
Industry bias