Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Departme… (NCT00621478) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
United States259 participantsStarted 2008-02
Plain-language summary
Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.
Who can participate
Age range3 Months – 18 Years
SexALL
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Inclusion criteria
✓. Age 3 months to less than 18 years;
✓. Generalized tonic clonic status epilepticus, defined as:
✓. Three or more generalized tonic clonic seizures within the last hour and currently experiencing a convulsion (i.e. the current convulsion may be the third convulsion within one hour); or
✓. Two or more generalized tonic clonic seizures in succession with no recovery of consciousness between seizures and currently experiencing a convulsion (i.e. the current convulsion may be the second convulsion without recovery of consciousness after the first convulsion); or
✓. A seizure that lasts at least 5 minutes that is either generalized tonic clonic in its entirety or starts focal and then generalizes. The seizure must be associated with loss of consciousness
Exclusion criteria
✕. Pregnancy;
✕. Shock prior to study drug (sustained hypotension requiring inotropic therapy);
✕. Significant dysrhythmia prior to study drug (other than sinus tachycardia);
✕. Need for emergent surgical intervention and general anesthesia for a condition present prior to study drug;
✕. Known sensitivity to benzodiazepines or known contraindication to benzodiazepine use; or
✕. Use of a benzodiazepine within 1 week of presentation.
What they're measuring
1
cessation of convulsions within 10 minutes of the initial administration of the study drug and a sustained absence of convulsions for 30 minutes from the initial administration of the study drug.
Timeframe: 30 minutes
Trial details
NCT IDNCT00621478
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)