An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain (Protocol No. B

Service: Trial Number:
076-12
Principal Investigator: Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
7-17 years
Gender:
Male & Female

This study is for the treatment of pain that needs treatment with a continuous (around the clock) dose of strong pain medicine. The investigational drug you will receive in this study is in a transdermal patch (placed on the skin) that gives a continuous dose of strong pain medicine that is absorbed through the skin. This patch is called Buprenorphine Transdermal System (BTDS.) It contains a drug called buprenorphine. The drug is a pain medicine that works by blocking pain messages to the brain. BTDS has not been approved by the Food and Drug Administration (FDA) to treat moderate to severe pain in children below the age of 18 years; and may only be given in research studies such as this one. The purpose of this research study is to study the side effects of BTDS and how well it works in children.