Fentanyl ITS Research Articles

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

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. 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. 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. 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.

Fentanyl Iontophoretic Transdermal System (IONSYS(®)) can be Safely used in the Hospital Environment with X-Rays, Computerized Tomography and Radiofrequency Identification Devices.

IntroductionFentanyl iontophoretic transdermal system (fentanyl ITS, IONSYS®) is a patient-controlled analgesia system used for the management of acute postoperative pain, designed to be utilized in a hospital setting. The objective of the two studies was to determine if fentanyl ITS could be safely used with X-rays, computerized tomography (CT) scans and radiofrequency identification (RFID) devices.MethodsThe ITS system has two components: controller and drug unit; the studies utilized ITS systems without fentanyl, referred to as the ITS Placebo system. The first study evaluated the effect of X-radiation on the operation of an ITS Placebo system. Five ITS Placebo systems were exposed to X-rays (20 and 200 mSv total radiation dose—the 200 mSv radiation dose represents a tenfold higher exposure than in clinical practice) while operating in the Ready Mode and five were exposed while operating in the Dose Mode. The second study evaluated the effect of RFID (worst-case scenario of direct contact with an RFID transmitter) on the operation of an ITS Placebo system. During these tests, observations of the user interface and measurements of output voltage confirmed proper function throughout all operational modes (Ready Mode, Dose Mode, End-of-Use Mode, and End-of-Life Mode).ResultsThe ITS Placebo system met all specifications and no functional anomalies were observed during and following X-ray exposure at two radiation dose levels or exposure at six different combinations of RFID frequencies and field strengths.ConclusionThe performance of the ITS system was unaffected by X-ray exposure levels well beyond those associated with diagnostic X-rays and CT scans, and by exposure to radiofrequency field strengths typically generated by RFID devices. These results provide added confidence to clinicians that the fentanyl ITS system does not need to be removed during diagnostic X-rays and CT scans and can also be utilized in close proximity to RFID devices.FundingThe studies and writing of this manuscript were supported financially by The Medicines Company.

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

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. 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). 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). 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.

Poster 136 Patient-Controlled Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) Improved Post-Operative Mobility Compared to Intravenous Patient-controlled Analgesia (IV PCA) Morphine: A Pooled Analysis of Randomized, Controlled Trials

Poster 136 Patient-Controlled Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) Improved Post-Operative Mobility Compared to Intravenous Patient-controlled Analgesia (IV PCA) Morphine: A Pooled Analysis of Randomized, Controlled Trials

Transdermal fentanyl patches versus patient-controlled intravenous morphine analgesia for postoperative pain management.

Background:Acute and severe pain is common in patients postoperatively and should be correctly managed. In the past years studies on preparing better postoperative pain control have resulted in development of postoperative pain management guidelines. Perhaps, one of the major improvements in managing postoperative pain is the development of the patient-controlled analgesia systems (PCA), especially through intra venous (IV), extradural and transdermal routes, which has resulted in marked improvements in acute postoperative pain management. Physicians administrate potent opioids for moderate to severe post-surgical pains. Morphine is the most commonly IV-PCA administrated analgesic. The fentanyl iontophoretic transdermal system (fentanyl ITS) is also another efficient option for pain management.Objectives:The aim of this study was to compare the analgesic effects of these two routine postoperative pain control systems.Patients and Methods:We enrolled 281 patients (224 males, 57 females) in this blind randomized controlled clinical trial, who had undergone an orthopedic surgery, with the mean age of 33.91 ± 14.45 years. Patients were randomly divided into two groups; in group A patients received IV-morphine PCA pump and in group B fentanyl transdermal patches were attached on patients’ arms. The severity of the pain was registered according to Visual Analogue Scale in specially designed forms by pain-trained nurses in two steps; first after the surgery and next before the beginning of analgesic effects. After 24 hours, the pain score was assessed again.Results:No significant difference was observed in mean pain intensity score at the first patient assessment. Mean pain intensity scores were also similar in both groups at the last measured time point (P > 0.05). Differential pain intensity scores, showing the impacts of analgesic system on the pain experience of the patients was also similar between fentanyl patches (6.48 ± 2.20) and morphine PCIA (6.40 ± 1.80). (P > 0.05) Mean patient satisfactory score (scale: 0–100) was also similar in both groups (P > 0.05). The percentage of patients, whose differential pain intensity scores at 24 hours reached our pain management goal was similar between fentanyl and morphine groups (P > 0.05). The percentage of patients with at least one adverse event was significantly higher in fentanyl group (P < 0.05). The most frequent adverse events were nausea, vomiting and itching. In none of the groups, no patient experienced serious adverse events related to the studied medications.Conclusions:Although both pain killing therapeutic regimens are safe and effective for postoperative pain management, regarding the easy usage of the patches, lower risk of abuse and cost-effectiveness in the Iranian market, it is recommended for use in Iranian hospitals and trauma centers and in countries with similar socioeconomic situations.

Nurse-Rated Ease of Care, Satisfaction, and Patient Mobility With Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) Versus IV PCA Morphine for Post-Operative Pain Management: A Pooled Analysis of 3 Randomized, Controlled Trials

Nurse-Rated Ease of Care, Satisfaction, and Patient Mobility With Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) Versus IV PCA Morphine for Post-Operative Pain Management: A Pooled Analysis of 3 Randomized, Controlled Trials

Prospective safety surveillance study of fentanyl HCl iontophoretic transdermal system (fentanyl ITS)

Prospective safety surveillance study of fentanyl HCl iontophoretic transdermal system (fentanyl ITS)

Physical Therapists' Perceptions of Ease of Care in Patients Receiving 2 Forms of Analgesia After Total Hip Arthroplasty

Pain management modalities that facilitate patient mobility may contribute to recovery after total hip replacement (THR) surgery. The aim of this study was to evaluate the impact of morphine intravenous (IV) patient-controlled analgesia (PCA) and the fentanyl iontophoretic transdermal system (fentanyl ITS) on physical therapists' ability to complete care tasks for patients after THR. The data were from an open-label, randomized, multicenter, active-control phase IIIb clinical trial. The settings were 52 US-based teaching and community hospitals. The patients were >or=18 years of age (mean [SEM]: 62.8 [0.6] years in the fentanyl ITS group and 62.9 [0.6] years in the morphine IV PCA group); had an American Society of Anesthesiologists physical status of I, II, or III; and were scheduled to undergo primary unilateral THR surgery. The patients were randomized to receive analgesia for up to 72 hours via the fentanyl ITS (40 microg of fentanyl over 10 minutes for up to 6 doses per hour for 24 hours or 80 doses per system, whichever occurred first) or morphine IV PCA (1-mg bolus doses [with a 5-minute lockout interval between doses] for up to 10 doses per hour for 24 hours). All patients received the usual treatment administered by physical therapists. After each therapy session, physical therapists completed a validated Physical Therapist Ease-of-Care Questionnaire, which included time efficiency and convenience subscales (lower scores indicated more positive responses) and a satisfaction subscale (a higher score indicated a more positive response). Therapists whose average scores were <or=2 on all items of the time efficiency and convenience subscales or >or=4 on both items of the satisfaction subscale were considered responders. Higher percentages of physical therapists were responders for the fentanyl ITS than for morphine IV PCA on the subscales that assessed time efficiency (84.9% and 59.1%, respectively), convenience (86.6% and 71.2%, respectively), and satisfaction (54.3% and 30.5%, respectively). Higher percentages of physical therapists favored the fentanyl ITS than favored morphine IV PCA. Limitations The trial was limited by its open-label design, and physical therapists were more familiar with IV PCA than with the fentanyl ITS. The findings demonstrate benefits to physical therapists of using the fentanyl ITS over morphine IV PCA in terms of time efficiency, convenience, and satisfaction.

Using the patient global assessment of the method of pain control to assess new analgesic modalities in clinical trials

ABSTRACTObjective: To assess the validity of the patient global assessment (PGA) of the method of pain control, a single-item patient-reported outcome measure of a method of pain control for patients experiencing postoperative pain.Research design and methods: Content validity of the PGA of the method of pain control was assessed using cognitive debriefing interviews. Construct validity was evaluated using data from six clinical trials that compared the efficacy of the fentanyl HCl iontophoretic transdermal system (fentanyl ITS) with morphine intravenous patient-controlled analgesia or placebo fentanyl ITS for acute postoperative pain management.Main outcome measures: To assess the construct validity of the PGA rating scale, four hypotheses were developed that related positive PGA ratings (‘good’ or ‘excellent’) to (1) lower pain intensity scores, (2) higher satisfaction ratings, (3) a greater propensity to select the assigned pain control method in the future, and (4) favorable ratings of ease of use/convenience on the Patient Ease-of-Care Questionnaire. Descriptive statistics were used to evaluate the association of pain intensity and Overall Ease-of-Care scores with PGA ratings. An exact linear-by-linear association test was conducted to evaluate the association of satisfaction ratings and propensity to select the pain control method in the future with PGA ratings.Results: Results of cognitive debriefing interviews indicated that the PGA incorporates patient perceptions of several aspects of treatment with an analgesic modality, including level of pain, ease of use, and control of administration. PGA ratings were associated in the expected direction with other patient-reported outcomes used in several clinical studies.Conclusions: Findings suggest that both the content and construct validity of the PGA of the method of pain control in clinical trial settings are supported. However, this conclusion is potentially limited by the use of a narrow range of therapeutic interventions and, in some cases, small sample sizes in the clinical trials used to assess construct validity. The PGA of the method of pain control is an informative and useful measure for assessing pain control provided by different drug delivery systems for patients experiencing postoperative pain.

Patient-controlled transdermal iontophoretic fentanyl system as an alternative to intravenous morphine PCA

Patient-controlled analgesia (PCA) with intravenous morphine is commonly used to control moderate-to-severe postoperative pain. The US FDA recently approved a transdermal system for patient-controlled iontophoretic delivery of fentanyl as an alternative treatment. Aside from the route of administration, other differences between these systems may result in differing adverse-effect profiles. This review compares the clinical utility of these two modalities. MEDLINE, Cinahl and Google Scholar searches for clinical trials (1982 through to July 2007) were performed. Search terms included transdermal analgesia, iontophoresis, patient-controlled analgesia, IONSYS™ and E-TRANS®. All trials comparing intravenous morphine PCA with the transdermal iontophoretic fentanyl system (fentanyl ITS) were included. CONSORT diagrams and adverse-event frequencies were available in all cases. Results demonstrated that fentanyl ITS and intravenous PCA morphine are equally effective analgesics for the management of acute postoperative pain. Fentanyl ITS is associated with fewer treatment failures due to adverse events (p = 0.046), less pruritus (p = 0.001) and less somnolence (p = 0.055). Intravenous PCA morphine is associated with fewer treatment failures due to inadequate analgesia (p = 0.001). It was concluded that fentanyl ITS is an equally safe and effective alternative to intravenous PCA morphine. Advantages favoring fentanyl ITS include convenience and ease-of-care.

Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management

The fentanyl iontophoretic transdermal system (fentanyl ITS) enables needle-free, patient-controlled analgesia for postoperative pain management. This study compared the efficacy, safety, and ease of care of fentanyl ITS with patient-controlled, i.v. analgesia (PCIA) with morphine for postoperative pain management. A prospective, randomized, multicentre trial enrolled patients in Europe after abdominal or orthopaedic surgery. Patients received fentanyl ITS (n = 325; 40.0 microg fentanyl over 10 min) or morphine PCIA [n = 335; bolus doses (standard at each hospital)] for < or =72 h. Supplemental i.v. morphine was available during the first 3 h. The primary efficacy measure was the patient global assessment (PGA) of the pain control method during the first 24 h. PGA ratings of 'good' or 'excellent' were reported by 86.2 and 87.5% of patients using fentanyl ITS or morphine PCIA, respectively (95% CI, -6.5 to 3.9%). Mean (sd) last pain intensity scores (numerical rating scale, 0-10) were 1.8 (1.77) and 1.9 (1.86) in the fentanyl ITS and morphine PCIA groups, respectively (95% CI, -0.38 to 0.18). More patients reported a system-related problem for fentanyl ITS than morphine PCIA (51.1 vs 17.9%, respectively). However, fewer of these problems interrupted pain control (4.4 vs 41.3%, respectively). Patients, nurses, and physiotherapists reported more favourable overall ease-of-care ratings for fentanyl ITS than morphine PCIA. Study termination rates and opioid-related side-effects were similar between groups. Fentanyl ITS and morphine PCIA were comparably effective and safe.

Acute postoperative pain management: focus on iontophoretic transdermal fentanyl

Despite progress in the management of chronic pain, acute pain remains an issue for many postoperative patients. Although patient-controlled analgesia (PCA) has demonstrated efficacy and patient satisfaction, current techniques using intravenous (IV) administration present limitations, including the risk of programming errors and the potential to limit patient mobility due to pumps, lines, and tubing. The patient-controlled fentanyl hydrochloride (HCl) iontophoretic transdermal system (fentanyl ITS) was designed to address these concerns. Fentanyl ITS is an innovative, needle-free, self-contained drug-delivery system that uses iontophoretic technology to deliver fentanyl through the skin by application of a low-intensity electrical field. The results of several clinical studies are presented in this review. In three phase 3 placebo-controlled trials, fentanyl ITS was shown to be superior to placebo for the treatment of postoperative pain following major abdominal, orthopedic, and thoracic surgery. The results of one active-comparator phase 3 trial demonstrated comparable safety and efficacy with a standard morphine IV PCA dosing regimen, without significant difference in the side effect profile. Fentanyl ITS represents a safe, easy to use, non-invasive, and convenient alternative to current acute postoperative pain management modalities.