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

Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: lorazepam or diazepam (Drug)

Phase: Phase 2/Phase 3

Status: Completed

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

Official(s) and/or principal investigator(s):
James Chamberlain, MD, Principal Investigator, Affiliation: Children's Research Institute

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.

Clinical Details

Official title: Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To determine population pharmacokinetics (PK) of lorazepam using sparse sampling.

feasibility of identifying patients for informed consent prior to arrival in status epilepticus for a randomized controlled trial

the experience of community consultation and public disclosure

feasibility of enrolling pediatric patients under an exception from informed consent

determine patients' and parents' attitudes and reactions to an exception from informed consent approach

severe or life-threatening respiratory depression

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 diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles. In the prehospital (Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without refrigeration. The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA.

Eligibility

Minimum age: 3 Months. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 3 months to less than 18 years; 2. Generalized tonic clonic status epilepticus, defined as: 1. 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 2. 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 3. 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: 1. Pregnancy; 2. Shock prior to study drug (sustained hypotension requiring inotropic therapy); 3. Significant dysrhythmia prior to study drug (other than sinus tachycardia); 4. Need for emergent surgical intervention and general anesthesia for a condition present prior to study drug; 5. Known sensitivity to benzodiazepines or known contraindication to benzodiazepine use; or 6. 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: 1. Pregnancy; 2. Use of a benzodiazepine within 1 week of presentation. 3. Parent/guardian refusal to give informed consent by the methods described; 4. 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;

Locations and Contacts

Alberta Children's Hospital, Calgary, Alberta T3B6A8, Canada

University of California- Davis Medical Center, Davis, California 95817, United States

Children's Hospital Colorado, Aurora, Colorado 80045, United States

Children's National Medical Center, Washington DC, District of Columbia 20010, United States

University of Maryland Hospital for Children, Baltimore, Maryland 21201, United States

University of Michigan Emergency Medicine Research, Ann Arbor, Michigan 48106, United States

Children's Hospital of Michigan, Detroit, Michigan 48201, United States

Children's Hospital of Buffalo, Buffalo, New York 14222, United States

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H8L1, Canada

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Children's Medical Center Dallas, Dallas, Texas 75390-9063, United States

Texas Children's Hospital, Houston, Texas 77030, United States

University of Utah Pediatric Emergency Medicine, Salt Lake City, Utah 84158, United States

Medical College of Wisconsin Children's Corporate Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: February 2008
Last updated: December 14, 2012

Page last updated: August 23, 2015

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