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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Case Western Reserve University |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00109395 |
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. The purpose of this study is to make sure that lorazepam, when given to children who are very sick in the Intensive Care Unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. Midazolam is already approved by the FDA for this use, but lorazepam is not, even though both drugs are commonly used for sedation.
Condition | Intervention | Phase |
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Conscious Sedation Ventilation Critical Illness |
Drug: Lorazepam |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Trial Comparing Lorazepam With Midazolam for Sedation of Mechanically Ventilated Pediatric Patients |
Estimated Enrollment: | 340 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lorazepam Intermittent bolus: Active Comparator
lorazepam administered by intermittent bolus
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Drug: Lorazepam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
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lorazepam continuous infusion: Active Comparator
lorazepam administered by continuous infusion
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Drug: Lorazepam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
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midazolam continous infusion: Active Comparator
midazolam administered by continous infusion
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Drug: Lorazepam
Intravenous dosage forms, administered at dose and frequency per protocol in order to achieve adequate sedation as measured by the Comfort score
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Lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the FDA for this indication in children. The purpose of this study, in response to the Written Request by FDA, is to determine the safety, efficacy, and dosage required for lorazepam compared with midazolam, which is approved by FDA for children for this indication.
Study participants must be children who are critically ill and receiving mechanical ventilation who require sedation. Participants will be randomized to lorazepam (intermittent bolus or continuous infusion) or midazolam (continuous infusion). Sedation will be monitored using the COMFORT score. Blood will be drawn to measure lorazepam/midazolam plasma concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and glycols) in patients receiving lorazepam.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106-6010 |
Principal Investigator: | Jeffrey L Blumer, MD, PhD | Case Western Reserve University |
Responsible Party: | Case Western University ( Jeffrey Blumer, MD, PhD ) |
Study ID Numbers: | HHSN275200403367C (contract) |
Study First Received: | April 27, 2005 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00109395 |
Health Authority: | United States: Food and Drug Administration |
Lorazepam Midazolam Best Pharmaceuticals for Children Act Critically ill |
pediatrics mechanical ventilation sedation |
Lorazepam Critical Illness Midazolam |
Neurotransmitter Agents Disease Attributes Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |