Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.

Study Type: Interventional
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
Enrollment: 45
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Tapentadol Oral Solution (OS)