Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial

SummaryBackgroundIn sub-Saharan Africa, rectal diazepam or intramuscular paraldehyde are commonly used as first-line anticonvulsant agents in the emergency treatment of seizures in children. These treatments can be expensive and sometimes toxic. We aimed to assess a drug and delivery system that is potentially more effective, safer, and easier to administer than those presently in use.MethodsWe did an open randomised trial in a paediatric emergency department of a tertiary hospital in Malawi. 160 children aged over 2 months with seizures persisting for more than 5 min were randomly assigned to receive either intranasal lorazepam (100 μg/kg, n=80) or intramuscular paraldehyde (0·2 mL/kg, n=80). The primary outcome measure was whether the presenting seizure stopped with one dose of assigned anticonvulsant agent within 10 min of administration. The primary analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00116064.FindingsIntranasal lorazepam stopped convulsions within 10 min in 60 (75%) episodes treated (absolute risk 0·75, 95% CI 0·64–0·84), and intramuscular paraldehyde in 49 (61·3%; absolute risk 0·61, 95% CI 0·49–0·72). No clinically important cardiorespiratory events were seen in either group (95% binomial exact CI 0–4·5%), and all children finished the trial.InterpretationIntranasal lorazepam is effective, safe, and provides a less invasive alternative to intramuscular paraldehyde in children with protracted convulsions. The ease of use of this drug makes it an attractive and preferable prehospital treatment option.