Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

Condition(s) targeted: Status Epilepticus; Convulsions

Intervention: intranasal lorazepam (Drug); intramuscular paraldehyde (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Malawi College of Medicine

Official(s) and/or principal investigator(s):
Elizabeth Molyneux, MRCPCH FFAEM, Study Director, Affiliation: College of Medicine, University of Malawi
Shafique Ahmad, MRCPCH FFAEM, Principal Investigator, Affiliation: College of Medicine University of Malawi

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.

Official title: A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Secondary outcome:

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

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.

Minimum age: 2 Months. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Paediatric Emergency Department, Queen Elizabeth Central Hospital, Blantyre, Malawi

Starting date: July 2004
Ending date: June 2005
Last updated: July 20, 2006