Fentanyl HCl Iontophoretic Transdermal System Research Articles

PSY48 - Economic Impact of Fentanyl HCL Iontophoretic Transdermal System Versus IV PCA In Acute Pain Management Following Surgery In The United Kingdom, Germany And Sweden

PSY48 - Economic Impact of Fentanyl HCL Iontophoretic Transdermal System Versus IV PCA In Acute Pain Management Following Surgery In The United Kingdom, Germany And Sweden

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

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

Efficacy and safety of fentanyl HCl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management for patient subgroups

Inadequate postoperative pain control remains a problem for many patients undergoing surgery. This study presents subgroup analyses from a large, randomized, multicentre, European study comparing the efficacy and safety of the fentanyl HCl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia for postoperative pain management. The efficacy and safety of the fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia were evaluated for patients divided by surgery type, sex, American Society of Anesthesiologists physical status and type of anaesthesia used during surgery. Efficacy measures included a patient global assessment of the method of pain control (a rating of 'good' or 'excellent' was considered as a success rating) and mean last pain intensity scores in the first 24 h. Discontinuation rates and the incidence of adverse events were also evaluated. Numerically similar percentages of patients in most subgroups reported success on the last patient global assessment in the first 24 h for both the fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia. Similar percentages of investigators reported success ratings on the investigator global assessment at the last assessment for both treatment groups regardless of surgery type, except for the knee surgery subgroup (fentanyl iontophoretic transdermal system, 75%; morphine intravenous patient-controlled analgesia, 95%). Mean last pain intensity scores in the first 24 h after surgery were similar in all subgroups. Rates of patient withdrawals and the incidence of adverse events were generally similar between treatment groups in the patient subgroups. The fentanyl iontophoretic transdermal system and morphine intravenous patient-controlled analgesia are comparably well tolerated and effective methods of pain control, regardless of sex, American Society of Anesthesiologists physical status or the type of anaesthesia used for surgery, and following most surgery types.

Safety and tolerability of fentanyl iontophoretic transdermal system: Findings from a pooled data analysis of four clinical trials

Acute postoperative pain remains inadequately managed. Although patient-controlled analgesia (PCA) represents a significant advance in postoperative pain management, drawbacks may include invasiveness and the potential for programming errors. The analysis presented here is based on pooled patient-level safety data from four multicenter, randomized, active-controlled trials that evaluated the safety and tolerability of the needle-free, preprogrammed fentanyl HCl iontophoretic transdermal system (ITS) versus morphine intravenous PCA for postoperative pzin management; the results for patients who received fentanyl ITS are presented here. Adverse events (AEs), serious AEs, and clinically relevant respiratory depression were assessed across patient subpopulations categorized by age. A total of 1288 patients, including 356 elderly (>65 years of age) patients, received fentanyl ITS following surgery. The most commonly reported AEs included nausea, fever, vomiting, headache, anemia, pruritus, and hypotension. The incidence of AEs was generally lower for elderly patients than for patients 65 years or younger. Application-site reactions were reported for 18.6 percent of patients using fentanyl ITS and were generally mild to moderate in severity. No cases of clinically relevant respiratory depression were reported for patients who received fentanyl ITS. The results demonstrate that fentanyl ITS is safe and well tolerated for postoperative pain management for patients overall and for subpopulations divided according to age.

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.

Patients' Assessment of the Convenience of Fentanyl HCl Iontophoretic Transdermal System (ITS) Versus Morphine Intravenous Patient-Controlled Analgesia (IV PCA) in the Management of Postoperative Pain After Major Surgery

The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is a compact, self-contained, needle-free system that has been approved for acute postoperative pain management in hospitalized adults. The objective of the present analysis was to evaluate patients' assessment of fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) convenience on 7 different subscales, using a validated patient ease of care (EOC) questionnaire in 2 prospective, open-label, randomized, phase IIIb clinical trials. Patients received fentanyl ITS or morphine IV PCA (N = 1,305) for up to 72 h after total hip replacement surgery (THR study) or abdominal or pelvic surgery (APS study). For the majority of items on the patient EOC questionnaire, trends suggest that greater percentages of patients reported the most positive response for fentanyl ITS than they did for morphine IV PCA in both studies; differences were particularly noteworthy for items on the Movement subscale. In the THR study, more patients in the fentanyl ITS group were responders compared with those in the morphine IV PCA group for the subscales Confidence with Device, Pain Control, Knowledge/Understanding, and Satisfaction. In the APS study, responder rates for these subscales did not differ between treatment groups. These findings indicate that patients assessed the EOC associated with fentanyl ITS higher compared with morphine IV PCA for the management of acute postoperative pain and suggest that fentanyl ITS has the potential to improve acute postoperative pain care for patients and nurses.

Efficacy and Safety of the Fentanyl Iontophoretic Transdermal System (ITS) and Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine for Pain Management Following Abdominal or Pelvic Surgery

The fentanyl HCl iontophoretic transdermal system (ITS) has effectively managed pain following several types of surgery. This study evaluated the efficacy, safety, and ease of care associated with fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) for pain management following abdominal or pelvic surgery. This open-label, multicenter, randomized, active-controlled, parallel-group, phase IIIb study enrolled 506 postoperative patients at 39 U.S. sites. Patients received fentanyl ITS (40 microg fentanyl/dose) or morphine IV PCA (1 mg morphine/dose). The primary efficacy measure was demonstrating equivalence on the patient global assessment (PGA) of the method of pain control in the first 24 hours of treatment between the groups. Percentages of patients in the fentanyl ITS and morphine IV PCA groups reporting PGA ratings of "good" or "excellent" in the first 24 hours were statistically equivalent (84.9% vs 84.3%, respectively; difference = 0.7%, 95% CI: -5.6% to 7.0%). Equivalence was also demonstrated based on mean last pain intensity scores in the first 24 hours (3.0 vs 2.9, respectively; difference = 0.1, 95% CI: -0.28 to 0.43). Overall discontinuation rates were not significantly different between groups (16.7% vs 11.8%, respectively; P = 0.128). Patients and nurses reported better ease-of-care ratings for fentanyl ITS than for morphine IV PCA. Commonly occurring adverse events were similar between groups. Fentanyl ITS and morphine IV PCA were comparable methods of pain control following abdominal or pelvic surgery; however, fentanyl ITS was rated better than morphine IV PCA for ease of care by patients and nurses.

The safety and tolerability of the fentanyl HCl iontophoretic transdermal system: An alternative to currently available analgesic modalities

The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is an analgesic modality approved for the management of acute postoperative pain. The fentanyl ITS uses a generally imperceptible electrical field to drive fentanyl across the skin and into the bloodstream. Unlike intravenous patient-controlled analgesia (PCA), fentanyl ITS is needle free and preprogrammed, eliminating the risks of needlestick injury and programming errors. Its efficacy, safety, and tolerability were assessed in several clinical trials, and this article presents the integrated safety and tolerability of fentanyl ITS using data pooled from these studies. Data were pooled from three placebo-controlled trials and one active-controlled trial (fentanyl ITS vs intravenous PCA morphine) in which patients 18 years or older were admitted to the postanesthesia care unit after major abdominal, orthopedic, or thoracic surgery. This analysis of safety and tolerability data revealed common treatment-related adverse events: nausea, vomiting, headache, and erythema. No clinically relevant respiratory depression was observed. No significant differences were observed between elderly patients (> or =65 years of age) and patients <65 years of age. The fentanyl ITS addresses certain safety issues of existing modalities while providing comparable pain relief making it an attractive option for postoperative pain management.

Current practices for postoperative pain management in Europe and the potential role of the fentanyl HCl iontophoretic transdermal system

Survey results continue to reveal that postoperative pain is insufficiently managed throughout Europe and the rest of the world. However, the efficient use of existing resources, as well as the introduction of novel technologies, may aid in its improvement. Use of an acute pain service has the potential to improve pain management through specialized patient care and utilization of effective analgesic techniques. Multimodal analgesic techniques, which include adjuvant non-opioids and/or regional analgesic techniques, can provide effective analgesia and reduce the amount of systemic opioids (or obviate the need) for postoperative pain management. Patient-controlled analgesia modalities may also offer improvements to pain management, as in practice they provide pain relief superior to the intermittent administration of bolus doses of opioids. A novel patient-controlled analgesia modality that has been approved by the European Medicines Evaluation Agency (EMEA) for the treatment of acute, moderate-to-severe pain is the needle-free, pre-programmed fentanyl HCl iontophoretic transdermal system. This system was shown in a recent US clinical trial to be comparable in efficacy to a standard regimen of morphine intravenous patient-controlled analgesia. Adverse events associated with the use of the fentanyl iontophoretic transdermal system are generally similar to those experienced by patients using intravenous morphine patient-controlled analgesia. Considerations regarding the selection of patients for treatment with the fentanyl iontophoretic transdermal system are similar to those with other patient-controlled analgesia modalities; sufficient upper limb mobility and alertness are required to operate the system. Utilization of the fentanyl iontophoretic transdermal system, together with the guidance of an effective acute pain service, may lead to improvements in postoperative pain management.

Fentanyl HCl iontophoretic transdermal system versus intravenous morphine pump after gynecologic surgery

To compare the efficacy and safety of fentanyl iontophoretic transdermal system (ITS) with morphine intravenous patient-controlled analgesia (IV PCA) for pain management following gynecologic surgery. A subgroup (n = 275) of gynecologic surgery patients from a randomized study (N = 636) of patients treated with fentanyl ITS or morphine IV PCA was analyzed. The main efficacy endpoint was the patient global assessment (PGA) of the method of pain control (first 24 h). In gynecologic surgery patients, PGA success ratings (excellent/good) were statistically equivalent (fentanyl ITS, 84.8%; morphine IV PCA, 83.9%; 95% confidence interval: -7.7%, 9.4%) based on the prespecified equivalence criterion of 10% for the entire study population. Pain intensity at 3 h (P = 0.296), discontinuations due to inadequate analgesia (P = 0.148), and percentages of patients requesting supplemental opioids in the first 3 h (P = 0.524) were similar. The two modalities were therapeutically equivalent for pain management in these gynecologic surgery patients.

Nurses’ views on ease of patient care in postoperative pain management

The fentanyl HCl iontophoretic transdermal system (ITS) is a compact, needle-free, pre-programmed patient-controlled analgesic system that was developed to address limitations to existing therapies for postoperative pain management. A randomized, controlled trial was conducted in 11 European countries to evaluate the efficacy and safety of postoperative pain control using fentanyl ITS compared with a standard regimen of morphine provided by an intravenous patient-controlled analgesia (IV PCA) pump. This article summarizes results from Nurse Ease-of-Care Questionnaires which were completed to assess the convenience and ease of use of each pain management modality from the perspective of the nurse. Nurses' ratings of patient-care tasks associated with each pain management system were significantly more favourable for fentanyl ITS than for morphine IV PCA. These findings suggest that nurses consider fentanyl ITS to be easier to use than morphine IV PCA.

Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: A comparative study with morphine intravenous patient-controlled analgesia

Background and Objectives: The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR). Methods: In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 μg fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings (“excellent” or “good”) on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed. Results: The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: −4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: −0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups. Conclusions: Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.

Fentanyl Iontophoretic Transdermal System for Acute-Pain Management After Orthopedic Surgery: A Comparative Study With Morphine Intravenous Patient-Controlled Analgesia

The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR). In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 mug fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings ("excellent" or "good") on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed. The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: -4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: -0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups. Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.