Lorazepam Sedation for Critically Ill Children

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Lorazepam; Midazolam

Criteria

Inclusion Criteria:

• Males or females from full term birth (at least 38 weeks post conceptual age) through 18 years

• Patients must be intubated and mechanically ventilated in the PICU less than or equal to 24 hr

• Patients in whom the use of neuromuscular blocking agents would normally NOT be expected to be used.

• Patient's parent or guardian has signed a consent form prior to initiation of study procedures

• Patients with cardiac, renal, or hepatic dysfunction will be actively sought

Exclusion Criteria:

• Life expectancy < 48 hr

• Expected duration of sedation < 48 hr

• Patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental

• Females pregnant or breast feeding

• Patient requires sedatives or analgesics other than study drug