Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Status:
Completed
Trial end date:
2011-04-18
Target enrollment:
Participant gender:
Summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication
may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
(pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
promotes opioids and no longer markets Opana® ER.