Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Kamuzu University of Health Sciences

Status and phase

Completed

Phase 3

Conditions

Status Epilepticus

Convulsions

Treatments

Drug: intramuscular paraldehyde

Drug: intranasal lorazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT00116064

P03/04/248

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 months to 12 years old

Volunteers

No Healthy Volunteers

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