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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)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: lorazepam or diazepam (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

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

Overall contact:
James Chamberlain, MD, Phone: 202-476-3253, Email: jchamber@cnmc.org

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

James Chamberlain, MD, Phone: 202-476-3253, Email: jchamber@cnmc.org

Alberta Children's Hospital, Calgary, Alberta T3B6A8, Canada; Not yet recruiting
Janielee Williamson, RN, Phone: 403-955-3186, Email: Janie.Williamson@albertahealthservices.ca
David Johnson, MD, Principal Investigator

University of California- Davis Medical Center, Davis, California 95817, United States; Recruiting
Shari Nichols, Phone: 916-734-7596, Email: shari.nichols@ucdmc.ucdavis.edu
Cheryl Vance, MD, Principal Investigator

Children's Hospital Denver, Aurora, Colorado 80045, United States; Recruiting
Kendra Kocher, Phone: 303-724-2592, Email: Kocher.Kendra@tchden.org
Joseph Grubenhoff, MD, Principal Investigator

Children's National Medical Center, Washington DC, District of Columbia 20010, United States; Recruiting
Jim Chamberlain, MD, Phone: 202-476-3253, Email: jchamber@cnmc.org

Children's National Medical Center, Washington DC, District of Columbia 20010, United States; Recruiting
Ebony Parham, Phone: 202-476-3718, Email: eparham@cnmc.org
Kathleen Brown, MD, Principal Investigator

University of Maryland Hospital for Children, Baltimore, Maryland 21201, United States; Recruiting
Bahiyyah Jackson, Phone: 410-706-0204, Email: bjackson@peds.umaryland.edu
Richard Lichenstein, MD, Principal Investigator

University of Michigan Emergency Medicine Research, Ann Arbor, Michigan 48106, United States; Recruiting
Philip Villanueva, Phone: 734-615-8981, Email: pvillanu@med.umich.edu
Rachel Stanley, MD, Principal Investigator

Children's Hospital of Michigan, Detroit, Michigan 48201, United States; Recruiting
Amy Stolinski, Phone: 313-745-1332, Email: astolins@med.wayne.edu
Prashant Mahajan, MD, Principal Investigator

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

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H8L1, Canada; Recruiting
Candice McGahern, Phone: 613-737-7600, Ext: 4111, Email: CMcGahern@cheo.on.ca
Roger Zemek, MD, Principal Investigator

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Joseph Mechak, Phone: 267-426-7932, Email: MECHAKJ@email.chop.edu
Jill Baren, MD, Principal Investigator

Children's Medical Center Dallas, Dallas, Texas 75390-9063, United States; Recruiting
Anne-Marie Jones, Phone: 214-456-8436, Email: annemarie.jones@childrens.com
Pam Okada, MD, Principal Investigator

Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting
Victor Gonzalez, MD, Phone: 832-824-5977, Email: vmgonza1@texaschildrens.org
Charles Macias, MD, MPH, Principal Investigator

University of Utah Pediatric Emergency Medicine, Salt Lake City, Utah 84158, United States; Recruiting
Kammy Jacobsen, Phone: 801-599-6403, Email: kammy.jacobsen@hsc.utah.edu
Maija Holsti, MD, MPH, Principal Investigator

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

Additional Information

Starting date: February 2008
Last updated: November 4, 2011

Page last updated: December 08, 2011

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