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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:
Case Western Reserve University The Emmes Company, LLC The EMMES Corporation