Meta-Analysis of the Ease of Care From the Nurses' Perspective Comparing Fentanyl Iontophoretic Transdermal System (ITS) Vs Morphine Intravenous Patient-Controlled Analgesia (IV PCA) in Postoperative Pain Management.

PURPOSE: The aim of this meta-analysis was to compare the ease of care (EOC) of fentanyl iontophoretic transdermal system (ITS) vs the morphine intravenous patient-controlled analgesia (IV PCA) as assessed by the nurse. DESIGN: Meta-analysis of three phase 3B randomized active-comparator trials. METHODS: This meta-analysis according to Cochrane's approach assessed EOC using a validated nurse questionnaire (22 items grouped into three subscales, which include time efficiency, convenience, and satisfaction) in adult patients treated with fentanyl ITS or morphine IV PCA for postoperative pain management. The weighted mean difference (WMD) between treatments was calculated. FINDING: EOC analyses were based on responses to questionnaires from 848 (fentanyl ITS) and 761 (morphine IV PCA) nurses. Fentanyl ITS was reported to provide significant advantages compared with morphine IV PCA in terms of nurses' overall EOC (WMD = -0.57, P < .0001) and each of the subscales: time efficiency (WMD = -0.58, P < .0001), convenience (WMD = -0.57, P < .0001), and satisfaction (WMD = -0.47, P < .0001). CONCLUSIONS: In this meta-analysis, fentanyl ITS is associated with a superior EOC profile from the nurses' perspective than morphine IV PCA.

Meta-Analysis of the Ease of Care From a Patients' Perspective Comparing Fentanyl Iontophoretic Transdermal System Versus Morphine Intravenous Patient-Controlled Analgesia in Postoperative Pain Management.

PURPOSE: The purpose of this meta-analysis was to evaluate patients' assessment of fentanyl iontophoretic transdermal system (ITS) and morphine intravenous patient-controlled analgesia (IV PCA) ease of care (EOC) using a validated patient EOC questionnaire. Fentanyl ITS is a preprogrammed, needle-free PCA system used for the management of acute pain in postoperative patients. METHODS: This meta-analysis assessed the patient EOC of fentanyl ITS and morphine IV PCA using data from three randomized, active-comparator trials in adult postoperative patients with moderate-to-severe pain. All three studies utilized a validated patient EOC questionnaire which consists of 23 items grouped into seven subscales (confidence with device, comfort with device, movement, dosing confidence, pain control, knowledge/understanding, and satisfaction). Each item is scored on a six-point Likert scale. The weighted mean difference between treatments was calculated for the overall EOC and for each of the seven subscales. RESULTS: The EOC analyses were based on responses to questionnaires from 1,943 patients treated with either fentanyl ITS (n = 961) or morphine IV PCA (n = 982). There was a statistically significant advantage in favor of fentanyl ITS over morphine IV PCA in terms of overall EOC (weighted mean difference = 0.28; 95% confidence interval (0.22 to 0.34); P < 0.0001). Five of the seven subscales (confidence with device, comfort with device, movement, dosing confidence, and knowledge/understanding) on the patient EOC questionnaire showed a statistically significant advantage for fentanyl ITS versus morphine IV PCA. The two subscales that did not show any difference were pain control (P = 0.7303) and satisfaction (0.0561). CONCLUSION: In this meta-analysis, fentanyl ITS is associated with some advantages in terms of an EOC profile from a patients' perspective when compared with morphine IV PCA.

Patient-Controlled Fentanyl Iontophoretic Transdermal System Improved Postoperative Mobility Compared to Intravenous Patient-Controlled Analgesia Morphine: A Pooled Analysis of Randomized, Controlled Trials.

BACKGROUND: Postoperative pain management protocols that use patient-controlled analgesia (PCA) can hinder mobility due to attached machinery and tubing. Immobility in the postoperative setting can increase complications, length of stay (LOS), and costs. Early and enhanced mobilization can reduce the cost of care while improving patient outcomes. A needle-free, compact, patient-activated, and portable fentanyl iontophoretic transdermal system (fentanyl ITS, IONSYS; The Medicines Company, Parsippany NJ) has been shown to provide comparable efficacy and tolerability to intravenous (IV) PCA morphine that promotes improved mobility. METHODS: This pooled analysis of 1,882 patients across three randomized, controlled trials compared fentanyl ITS to IV PCA morphine for postoperative pain management. Outcomes of patient mobility were assessed by a validated Patient Ease of Care Questionnaire that was given to patients, patients' nurses, and physical therapists involved in patient care. Safety was assessed via spontaneously reported treatment-emergent adverse events (TEAE). RESULTS: Fentanyl ITS significantly improved overall patient mobility, each mobility subscore (P < 0.0001) across all demographics (male/female; elderly/non-elderly; normal BMI/overweight/obese/morbidly obese) and surgery types, and was consistent across nurses and physical therapists mobility assessments. TEAEs were generally similar between the two groups. However, more patients reported an opioid-related TEAE with morphine IV PCA than with fentanyl IV PCA (P = 0.003). CONCLUSION: Due to improved mobility with fentanyl ITS, complications are expected to be less frequent than with IV PCA and epidural PCA. Incorporation of this strategy into postoperative pain management protocols may reduce LOS and total hospital costs.

Patient considerations in the use of transdermal iontophoretic fentanyl for acute postoperative pain.

Opioids are commonly used in the management of moderate-to-severe postoperative pain. Patient-controlled analgesic techniques are recognized as preferred administration methods. Previously, research has focused on intravenously administered opioids via a programmable pump. More recently, an iontophoretic transdermal system (ITS), which is patient controlled, has been developed. The focus of this review is on pain management using the fentanyl ITS during the 24-72-hour time period immediately following surgery. Fentanyl ITS offers a needle-free alternative to traditional intravenous (IV) patient-controlled analgesia (PCA) system that is as effective and safe as IV PCA. This system is easy to use for both patients and nurses. The use of fentanyl ITS is generally associated with a better ease-of-care profile, including a greater ease of mobility, from a patients' perspective when compared with morphine IV PCA.

Ease-of-care from the physical therapists' perspective comparing fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia in postoperative pain management.

AIM: To compare the ease-of-care (EOC) examining time efficiency, convenience and satisfaction of fentanyl iontophoretic transdermal system ([ITS] IONSYS®) and morphine intravenous patient-controlled analgesia (iv. PCA) in postoperative pain management using a validated physical therapist (PT) EOC questionnaire. MATERIALS & METHODS: This meta-analysis assessed EOC of fentanyl ITS versus morphine iv. PCA using data from two randomized, active-comparator studies (fentanyl ITS: n = 720 and morphine iv. PCA: n = 739) which used the PT EOC questionnaire (22 items grouped into three subscales; time efficiency, convenience and satisfaction). Each item was scored on a 6-point Likert scale. For time efficiency, PT whose average scores were ≤2 on all items of the time efficiency and convenience subscales or ≥4 on both satisfaction items were considered responders. RESULTS: There were EOC questionnaires from 264 (fentanyl ITS) and 254 (morphine iv. PCA) PTs. There were significantly greater proportions of PTs classified as responders for fentanyl ITS than morphine iv. PCA for overall EOC (81.0 vs 55.7%, respectively), time efficiency (83.1 vs 59.5%, respectively), convenience (87.4 vs 72.0%, respectively) and satisfaction (51.9 vs 30.0%, respectively), all p < 0.0001. CONCLUSION: In this meta-analysis, fentanyl ITS is associated with a superior EOC profile (overall, time efficiency, convenience and satisfaction) from the PTs' perspective when compared with morphine iv. PCA.