drugset / Trial / NCT00109395
Lorazepam Sedation for Critically Ill Children
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lorazepam | Small molecule | — | Intravenous |
| Comparator | Midazolam | Small molecule | — | Intravenous |
Indications
No indication recorded.