Summary of findings 8. Summary of findings table ‐ Lignocaine versus benzodiazepines as second‐line ASM for EEG‐confirmed neonatal seizures.
Lignocaine versus benzodiazepines as second‐line ASM for EEG‐confirmed neonatal seizures | ||||||
Patient or population: neonates with EEG‐confirmed seizures Setting: Neonatal intensive care unit Intervention: lignocaine as second‐line ASM Comparison: benzodiazepines as second‐line ASM | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with benzodiazepines as second‐line ASM | Risk with lignocaine as second‐line ASM | |||||
Proportion of infants who achieve seizure control after first loading dose of ASM ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ | The included trial did not report this outcome. |
Proportion of infants who achieve seizure control after maximal loading dose of ASM | 0 per 1000 | 0 per 1000 (0 to 0) | RR 8.17 (0.52 to 128.42) | 11 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | |
Mortality or neurodevelopmental disability at 12 months | 1000 per 1000 | 1000 per 1000 (710 to 1000) | RR 1.00 (0.71 to 1.41) | 10 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c | |
Mortality before hospital discharge | 333 per 1000 | 400 per 1000 (83 to 1000) | RR 1.20 (0.25 to 5.71) | 11 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c | |
Neurodevelopmental disability at 12 months | 600 per 1000 | 600 per 1000 (216 to 1000) | RR 1.00 (0.36 to 2.75) | 10 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c | |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_438957465149804345. |
a Downgraded by two levels for very serious risk of bias due to high risk of bias in the only included trial b Downgraded by two levels for very serious imprecision due to very low sample size and event rate not meeting the 'Optimal Information Size' criteria c Downgraded by one level for serious indirectness of the intervention as the study population included neonates who required second‐ and third‐line ASMs as well