Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System--Issues Involving Patient Enrollment

Hiraki, Stephanie J., Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System-Issues Involving Patient Enrollment. Master of Science (Clinical Research Management), May 2005, 112 pp., 2 tables, 6 illustrations, bibliography, 42 titles. An open label, randomized, comparative, parallel, phase III multicenter study will be the main focus in the surgery department at the University of North Texas Health Science Center Patient Care Center. The study will evaluate the safety and efficacy of the fentanyl patient-controlled transdermal system (PCTS) versus an intravenous patient controlled anesthesia morphine pump (PCA pump) for abdominal surgery postoperative pain management. Patient enrollment is essential. Slow patient enrollment in clinical trials will lead to a delay in the sponsor’s submission of the investigational product for review and approval from the FDA. The barriers and facilitators to the accrual and retention of patients in this study will be covered.