Extrait

The primary objective of this study is to demonstrate the superiority of Ionsys over morphine IV PCA with regard to the patient's ability to mobilise during the management of acute moderate to severe post-operative pain. Ability to mobilise will be assessed through a combined analysis of patient responses to three validated questions: 1). Because of the system/device I had to be careful when I used my hands or arms (to eat, brush teeth or sit up in bed) 2). The system/device made it difficult for me to adjust my position in bed 3). The system/device interfered with my ability to get out of bed and walk around (to chair in room, to bathroom in room/ward, to hallway).

Critère d'inclusion

• Evaluation of the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal PCA system (Ionsys) and morphine IV PCA for management of acute moderate to severe post-operative pain in patients who have undergone elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty)

Liens

• euctr
• ictrp