Clinical trial NCT00116064: Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Status Epilepticus
Convulsions
Keywords: intranasal
lorazepam
paediatric
convulsions
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
First posted: 2005-06-27
Enrollment: 156
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
Secondary outcomes:
measure: time from drug administration to cessation of convulsion
measure: frequency of episodes requiring 2 or more anticonvulsant agents
measure: continuous blood pressure and oxygen saturation for 30 minutes post drug administration
measure: seizure recurrence within 24 hours of cessation of presenting convulsion
measure: survival/death
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Paediatric Emergency Department, Queen Elizabeth Central Hospital
Study officials:
affiliation: Kamuzu University of Health Sciences
name: Elizabeth Molyneux, MRCPCH FFAEM
role: STUDY_DIRECTOR
affiliation: Kamuzu University of Health Sciences
name: Shafique Ahmad, MRCPCH FFAEM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7. doi: 10.1016/S0140-6736(06)68696-0.