Ahmad 2006.
Methods | Randomised controlled trial carried out over 12 months in Malawi | |
Participants | 160 children of both sexes and aged 2 months to 12 years presenting to a paediatric emergency department in a generalised seizure. Exclusion criteria: features of hepatic or hypertensive encephalopathy or organophosphate poisoning, children who had received an anticonvulsant within 1 hour of presentation | |
Interventions | Intranasal lorazepam versus intramuscular paraldehyde | |
Outcomes | Seizure cessation Incidence of cardiorespiratory depression Need for further anti‐convulsant/s | |
Notes | Study conducted in Africa with a high proportion of children with either cerebral malaria or meningitis. Consequently, not readily generalisable to western populations | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Blocked randomisation was done in advance by a computer that randomly generated a table of numbers in batches of ten" Comment: adequate randomisation |
Allocation concealment (selection bias) | Low risk | Quote: " treatment allocations were sealed in unmarked identical envelopes. Investigators were masked to these allocations before the point of patient treatment. Quote: adequate concealment |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study unblinded, but blinding would have been difficult due to the different routes of administration of the 2 study drugs. This is not likely to have affected outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the final analysis |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported in the Results section |
Other bias | High risk | A high proportion of the children recruited had either cerebral malaria or meningitis. These comorbidities may have impacted upon the results |