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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal lorazepam | Drug | |||
| intramuscular paraldehyde | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Molyneux, MRCPCH FFAEM | Kamuzu University of Health Sciences | Study Director |
| Shafique Ahmad, MRCPCH FFAEM | Kamuzu University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paediatric Emergency Department, Queen Elizabeth Central Hospital | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16698412 | Result | 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. |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| seizure recurrence within 24 hours of cessation of presenting convulsion |
| survival/death |