S. Bhananker, M.D.
This open-label, 2-part, ascending-dose,multicenter study is designed to gain experience with a classic, single-dose and multiple dose postoperative treatment paradigm utilizing oxymorphone IR tablets in 6-17 year old subjects with postoperative pain requiring an opioid. The primary objective of the Single-dose Period is to determine the safety of oxymorphone IR in children aged 6-17 years requiring an opioid to treat their acute postoperative pain of various etiologies. The primary objective of the Multiple-Dose Period is to determine the effectiveness/clinical utility of oxymorphone IR in this subject population. The secondary objective is to determine the appropriate dosing recommendations for oxymorphone IR in this subject population.