A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

Summary

The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).

Timeline

Start

2004-10

Primary completion

2007-08

Completion

2007-09

Publications

• Results Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.

Drugs

Indications

No indication recorded.