Horowitz 1981.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Australia Follow‐up period: 48 hours | |
Participants | Randomly assigned: N = 24
Age, years, mean (standard error)
Gender, male, % (n/N)
Inclusion criteria
Exclusion criteria
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Interventions | Lidocaine: 100 mg/bolus, infusion of 3 mg/min for 1 hour; thereafter, reduced to 2 mg/min after 1 hour Mexiletine: 200 mg/bolus, infusion of 1 mg/min for 1 hour; thereafter, reduced to 0.5 mg/min after 1 hour Co‐interventions: electroversion, bolus of mexiletine (200 mg) or lidocaine (100 mg) (page 410) | |
Outcomes | Ocurrence of complex ventricular tachyarrhythmia Comment: Trial did not assess the outcome explicitly | |
Notes | Sample size calculation a priori: not reported
Sponsor: Austin Hospital Research Foundation Role of sponsor: support of the study Trial conduction dates: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "... were randomised and allocated to receive..." (page 410) 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’ "Patients who had persisted multifocal ventricular extrasystoles or ventricular tachycardia or ventricular fibrillation... were given additional bolus of 200 mg of mexiletine or 100 mg of lignocaine" (page 410) This trial did not report whether the co‐intervention (additional bolus) was allocated concealment or not |
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 | Withdrawal from study, % (n/N)
Reasons
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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) Comment: This trial did report safety Quote: "the greater efficacy of mexiletine was not associated with increased drug toxicity" (page 409) |
Other bias | High risk | Design bias and bias in presentation of data (Porta 2008) |