Status:
COMPLETED
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Status Epilepticus
Eligibility:
All Genders
3-18 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diaz...
Eligibility Criteria
Inclusion
- 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
- 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.
- Certain exclusion criteria may not be known at the time of drug administration due to the need for emergent treatment. Thus patients will be terminated from the study (early terminators) if the investigators discover any of the following conditions after administration of study drug:
- Pregnancy;
- Use of a benzodiazepine within 1 week of presentation.
- Parent/guardian refusal to give informed consent by the methods described;
- Patient's refusal to assent (for patients ≥ 7 yrs old and mentally competent to understand study procedures) by the methods described, or as required by the local IRB;
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT00621478
Start Date
February 1 2008
End Date
May 1 2012
Last Update
December 18 2012
Active Locations (14)
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1
University of California- Davis Medical Center
Davis, California, United States, 95817
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
University of Maryland Hospital for Children
Baltimore, Maryland, United States, 21201