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


METHODS
We 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 microg/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.


RESULTS
Intranasal 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.


CONCLUSIONS
Intranasal 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.
Ahmad
Shafique
S
Department of Paediatrics, College of Medicine, University of Malawi, Malawi. doctorshaf@hotmail.com
Ellis
Jane C
JC
Kamwendo
Hastings
H
Molyneux
Elizabeth
E
D000281:Administration, Intranasal; D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000150:complications; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D008140:Lorazepam / Q000008:administration & dosage / Q000627:therapeutic use*; D008295:Malawi; D008297:Male; D010242:Paraldehyde / Q000008:administration & dosage / Q000627:therapeutic use*; D012640:Seizures / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome
D000927:Anticonvulsants; D008140:Lorazepam; D010242:Paraldehyde