Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Status Epilepticus |
Intervention | Drug: lorazepam or diazepam |
Phase | Phase 2/Phase 3 |
Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Responsible Party | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier | NCT00621478 |
First Received | February 20, 2008 |
Last Updated | December 14, 2012 |
Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | February 20, 2008 |
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Last Updated Date | December 14, 2012 |
Start Date | February 2008 |
Estimated Primary Completion Date | May 2012 |
Current Primary Outcome Measures | 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. [Time Frame: 30 minutes] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2) |
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Official Title | Use Of Lorazepam For The Treatment Of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial Of Lorazepam And Diazepam |
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 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. |
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. |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Status Epilepticus |
Intervention | Drug: lorazepam or diazepam Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing. The medication will be administered as a slow IV push. Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 259 |
Estimated Completion Date | May 2012 |
Estimated Primary Completion Date | May 2012 |
Eligibility 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; |
Gender | Both |
Ages | 3 Months |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00621478 |
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Other Study ID Numbers | N01HD043393 |
Has Data Monitoring Committee | Yes |
Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Collaborators | Not Provided |
Investigators | Principal Investigator: James Chamberlain, MD Children's Research Institute |
Verification Date | July 2012 |
Locations[ + expand ][ + ]
University of California- Davis Medical Center | Davis, California, United States, 95817 |
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Children's Hospital Colorado | Aurora, Colorado, United States, 80045 |
Children's National Medical Center | Washington DC, District of Columbia, United States, 20010 |
University of Maryland Hospital for Children | Baltimore, Maryland, United States, 21201 |
University of Michigan Emergency Medicine Research | Ann Arbor, Michigan, United States, 48106 |
Children's Hospital of Michigan | Detroit, Michigan, United States, 48201 |
Children's Hospital of Buffalo | Buffalo, New York, United States, 14222 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States, 19104 |
Children's Medical Center Dallas | Dallas, Texas, United States, 75390-9063 |
Texas Children's Hospital | Houston, Texas, United States, 77030 |
University of Utah Pediatric Emergency Medicine | Salt Lake City, Utah, United States, 84158 |
Medical College of Wisconsin Children's Corporate Center | Milwaukee, Wisconsin, United States, 53226 |
Alberta Children's Hospital | Calgary, Alberta, Canada, T3B6A8 |
Children's Hospital of Eastern Ontario | Ottawa, Ontario, Canada, K1H8L1 |