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The purpose of this study is to evaluate the effectiveness, tolerability and safety of oxymorphone HCL immediate-release (IR) oral liquid when used to relieve acute postoperative pain in pediatric patients. Although approved by the U.S. Food and Drug Administration for treating moderate to severe pain in adults, it has not yet been approved for use in children.
Subject to certain exclusions, this study is open to patients of both genders, from infants through age 12, who are scheduled for a surgical procedure.
Males: Infant to 12 years
Females: Infant to 12 years
Participants will be randomly assigned to Part 1 or Part 2 of the study. Participants in the first group will receive a single dose of the study drug following surgery. Those in the second group will receive multiple doses – 1 following surgery and 1 dose every 4 to 6 hours for up to 48 hours. During the postoperative period, researchers will follow-up with participants at specified intervals to assess their level of pain management and other vital functions.
Visits: Requires hospitalization for surgery
Duration: 24 hours for participants in Part 1, and 48 hours for Part 2
Endo Pharmaceuticals Inc.
Study Description at National Institutes of Health
Mihaela Visoiu, MD
For information, please contact:
Denise McCarthy RN, CRC
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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