Cuendet 1988.
Study characteristics | ||
Methods | Parallel design (2 arms) Country: Switzerland Follow‐up period: 24 hours | |
Participants | Randomly assigned: N = 19
Age, years, mean (SE or SD)
Gender, male, % (n/N)
Inclusion criteria
Exclusion criteria: not reported |
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Interventions | Lidocaine, infusion at mean dose of 42 (8.8) µg/min/kg Pirmenol, infusion at mean dose of 6.1 (1.6) µg/min/kg Co‐interventions: not reported | |
Outcomes | Prevalence of ventricular arrhythmias (non‐ventricular fibrillation). Safety |
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Notes | A priori sample size estimation: no Sponsor: not reported Data were taken from "Resumés du XVIII. Congres de I Union Therapeutique Internationale" (date: unclear) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | " ...have been randomised..." (page 158) 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 | Quote: "Double blind randomized study" (page 158) 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) | High risk | The study report fails to include results for a key outcome that would be expected to have been reported in such a study
Comment: This study did not report mortality and ventricular fibrillation ≥ 1 outcomes of interest in the review are reported incompletely, so they cannot be entered into a meta‐analysis Quote: "...side effects have been observed in 10 pts, 5 in each group, but interruption of treatment was not necessary" (page 158) |
Other bias | High risk | Design bias (Porta 2008) Bias in presentation of data (Porta 2008) |