drugset / Trial / NCT00109395

Lorazepam Sedation for Critically Ill Children

NCT00109395

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2004-09
Primary completion
2007-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lorazepam Small molecule Intravenous
Comparator Midazolam Small molecule Intravenous

Indications

No indication recorded.