Abstract ID: A40
Abstract Title: Postoperative Pain Management Using the Fentanyl Patient-controlled Transdermal System (PCTS) versus Morphine Intravenous Patient-controlled Analgesia (IV PCA) Following Abdominal or Pelvic Surgery: Evaluation of Ease of Care
Authors: Yarmush J1, Vallow S2, Gargiulo K3, Hewitt D4
New York Methodist Hospital Brooklyn NY 1, Johnson & Johnson Raritan NJ 2, Johnson & Johnson Raritan NJ 3, Johnson & Johnson Raritan NJ 4
Poster Type: Poster
ABSTRACT BODY
Introduction: Moderate-to-severe postoperative pain is commonly treated using intravenous patient-controlled analgesia (IV PCA) with morphine. Although this method of pain control provides effective analgesia, it is often limited by its requirement for patient attachment to an IV line connected to a pole and a pump. An innovative, needle-free, fentanyl HCl patient-controlled transdermal system (fentanyl HCl PCTS; IONSYS™, Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, USA) has previously been shown to be as effective as IV PCA (morphine) for the management of moderate-to-severe, acute postoperative pain. A recently completed phase IIIb study evaluated the efficacy, safety, and ease of care of IONSYS vs IV PCA (morphine) for the management of acute postoperative pain following abdominal or pelvic surgery. The current analysis of that study evaluated the relative ease of use, effectiveness, and convenience of IONSYS vs IV PCA using validated Ease-of-Care (EOC) questionnaires from the perspective of the patient and nurse.
Methods: This was a multicenter, randomized, open-label, phase IIIb clinical trial of 506 patients who underwent abdominal or pelvic surgery at 39 sites. Following surgery, patients were randomized 1:1 and treated for up to 72 hours with IONSYS (40-μg on-demand dose [10-minute infusion]; 6 doses/hour maximum) or IV PCA morphine (1-mg bolus dose; 5-minute lockout between doses; 10 doses/hour maximum). Ease of care was evaluated as a secondary endpoint using validated EOC questionnaires. Patient EOC questionnaires were completed by the patient at 72 hours or upon withdrawal from the study. Floor nurses and research nurses who provided primary care for participating patients completed the Nurse EOC questionnaire after 10 patients completed the study at their respective centers. Both questionnaires comprised items scored on a 6-point Likert scale, ranging from 0=“not at all” to 5=“a very great deal;” questions that evaluated satisfaction were scored using a 6-point scale ranging from 0=“extremely dissatisfied” to 5=“extremely satisfied.” Better ease of care was indicated with higher scores on the patient questionnaire and lower scores on the nurse questionnaire. Statistical significance between the groups was determined using ANOVA for the Patient EOC data and a paired t-test for the Nurse EOC data.
Results: Results from Patient EOC questionnaires indicated better overall ease of care with IONSYS compared with IV PCA (P<0.0001), with significantly higher scores reported on the Confidence With Device, Comfort With Device, Mobility, Dosing Confidence, and Knowledge/Understanding subscales (P<0.05). Nurses also reported better overall EOC scores for IONSYS compared with IV PCA (P<0.0001), with significantly better scores reported on the Time-consuming, Bothersome, and Satisfaction subscales (P<0.0001).
Conclusions: Results of this study allow a comparison of the ease of care using two analgesic modalities from the perspectives of patients and nurses and show superior overall ease of care for IONSYS compared with IV PCA.
Acknowledgments: Supported by Ortho-McNeil, Inc.
ATTACHED FILES
Reg Anesth Pain Med 2005; 30(3):A40