Convulsions, Status Epilepticus
Conditions
Keywords
intranasal, lorazepam, paediatric, convulsions
Brief summary
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
Detailed description
The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.
Interventions
DRUGintranasal lorazepam
DRUGintramuscular paraldehyde
Sponsors
Kamuzu University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged between 2 months and 12 years * Presenting with generalised convulsions
Exclusion criteria
* Any child who had received an anticonvulsant agent within 1 hour of presentation * Seizure stopped with rapid cooling or treatment of hypoglycaemia * Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| time from drug administration to cessation of convulsion | — |
| frequency of episodes requiring 2 or more anticonvulsant agents | — |
| continuous blood pressure and oxygen saturation for 30 minutes post drug administration | — |
| seizure recurrence within 24 hours of cessation of presenting convulsion | — |
| survival/death | — |
Countries
Malawi
Outcome results
None listed