Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)

Completed · Phase 2/Phase 3

Conditions studied: Status Epilepticus

In brief

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.

Key facts

Study ID

NCT00621478

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

259

Starts

2008-02-01

Expected to finish

2012-05-01

Last updated by the study team

2012-12-18

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• University of California- Davis Medical Center — Davis, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Maryland Hospital for Children — Baltimore, Maryland, United States
• University of Michigan Emergency Medicine Research — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Children's Hospital of Buffalo — Buffalo, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Utah Pediatric Emergency Medicine — Salt Lake City, Utah, United States
• Medical College of Wisconsin Children's Corporate Center — Milwaukee, Wisconsin, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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