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

Hartrick, Craig T.; Bourne, Michael H.; Gargiulo, Kathryn; Damaraju, C. V.; Vallow, S.; Hewitt, David

doi:10.1016/j.rapm.2006.08.011

Cited by 45 publications

(59 citation statements)

References 5 publications

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“…Similar satisfaction and pain intensity score reporting was repeated in further active-comparator studies (Table 1) (Viscusi et al 2004; Hartrick et al 2006; Minkowitz et al 2007). There were no significant differences in the rate of withdrawal of patients from these studies due to inadequate analgesia (around 10%–15% in both iv PCA and ITS groups).…”

Section: Efficacy Studiessupporting

confidence: 58%

Advances in patient-controlled analgesia: the role of fentanyl ITS

Power¹,

McCormack²

2009

MDER

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Effective pain relief is an essential component of a patient’s peri-operative care package. Good analgesia has been shown to reduce the incidence of cardiovascular, respiratory and thrombo-embolic complications following surgery. Satisfactory analgesia facilitates early patient ambulation following surgery, which may reduce in-patient stay. Patient-controlled analgesia (PCA) systems are a well established standard therapy for acute post-operative pain; however some practical limitations limit their clinical utility. The fentanyl inotophoretic transdermal system (ITS) is a novel self-contained needle-free PCA device, which delivers boluses of fentanyl transdermally. This system has been shown to provide analgesia equivalent to conventional PCA modalities, with unique design features that may confer advantages to patients and staff, including facilitating patient mobilization in the post-operative phase. This review will discuss the technology of iontophoretic systems, the pharmacology of transdermal fentanyl delivery, and some practical implications of the fentanyl ITS.

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Section: Efficacy Studiessupporting

confidence: 58%

Advances in patient-controlled analgesia: the role of fentanyl ITS

Power¹,

McCormack²

2009

MDER

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“…Fentanyl ITS 40 µg up to 6 doses/h316Up to 72 hFentanyl ITS equivalent to morphine IV PCA (patient global assessment of the method of pain control during the first 24 h)B. Morphine IV PCA (1 mg/dose) up to 10 doses/h320 Hartrick et al [8]OrthopedicA. Fentanyl ITS 40 µg up to 6 doses/h395Up to 72 hFentanyl ITS equivalent to morphine IV PCA (patient global assessment ratings of the method of pain control of either “excellent” or “good” in the first 24 h)B.…”

Section: Methodsmentioning

confidence: 99%

High Body Mass Index and Use of Fentanyl Iontophoretic Transdermal System in Postoperative Pain Management: Results of a Pooled Analysis of Six Phase 3/3B Trials

et al. 2016

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IntroductionPostoperative pain management can be challenging in patients with a high body mass index (BMI) especially as a result of poor venous access and delayed ambulation that can result in serious complications. Fentanyl iontophoretic transdermal system (ITS) is a needle-free, patient-controlled analgesic method available for use in acute postoperative pain. The primary objective of these analyses was to determine if there were any differences between patients with high BMI (>40 kg/m2) and lower BMIs (<30 kg/m2 and 35–40 kg/m2) in terms of efficacy or safety.MethodsData from three registration, placebo-controlled trials and three active-comparator trials using fentanyl ITS (IONSYS®, The Medicines Company, Parsippany, NJ) for the management of postoperative pain were analyzed using BMI categories of <35 kg/m2, 35–40 kg/m2, and >40 kg/m2. The majority of patients had lower abdominal or orthopedic surgery. For these analyses, the primary efficacy variables were assessed via patient global assessment of pain control (PGA) at 24 h and investigator global assessment (IGA) at study discharge. PGA and IGA are categorical 4-point scales (excellent, good, fair, or poor) with treatment “success” defined as either excellent or good. Safety was evaluated via treatment emergent adverse events (TEAEs).ResultsThere were 1403 patients randomly assigned and treated with fentanyl ITS for at least 3 h (BMI <35 kg/m2: 1180; 35–40 kg/m2: 136, BMI >40 kg/m2: 85; and 2 missing). PGA treatment success, which evaluates the method of pain control, at 24 h was consistent in the high and low BMI groups in patients treated with fentanyl ITS (<35 kg/m2: 946/1180 [80.2%]; 35–40 kg/m2: 103/136 [75.7%]; and >40 kg/m2: 65/85 [76.5%]). The IGA results at study discharge were similar to the PGA. Safety appeared similar with fentanyl ITS across the BMI groups.ConclusionIn these analyses, fentanyl ITS was as efficacious, as assessed by the PGA ratings of treatment “success”, in patients with high BMI (>40 kg/m2) as it was for those with lower BMIs (<35 kg/m2 or 35–40 kg/m2) and was generally well tolerated across all BMI categories.

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“…A second clinical trial was a randomized controlled comparison of the fentanyl iontophoretic system and an intravenous morphine pump in patients following major surgery and demonstrated that the noninvasive fentanyl system produced postsurgical pain control that was equivalent to that provided by the intravenous morphine pump [37]. Subsequent clinical trials demonstrated efficacy in controlling pain after orthopedic and gynecological surgery [38,39]. However, despite these encouraging results, the marketing authorization for Ionsys was suspended by the European Medicines Agency in 2009 following the identification of corrosion of one component in the system in one batch of the product; the authorization was not renewed.…”

Section: Physical Enhancement Strategiesmentioning

confidence: 99%

Turning Theory into Practice: The Development of Modern Transdermal Drug Delivery Systems and Future Trends

Perumal

Murthy²

2013

Skin Pharmacol Physiol

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Despite its remarkable barrier function, the skin remains an attractive site for systemic drug delivery given its easy accessibility, large surface area and the possibility to bypass the gastrointestinal tract and the liver and so modify drug absorption kinetics. The pioneering work of Scheuplein, Higuchi and others in the 1960s helped to explain the processes involved in passive percutaneous absorption and led to the development of mathematical models to describe transdermal drug delivery. The intervening years have seen these theories turned to practice and a significant number of transdermal systems are now available including some that employ active drug delivery. This review briefly discusses the evolution of transdermal therapeutic systems over the years and the potential of newer transdermal technologies to deliver hydrophilic drugs and macromolecules through the skin.

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

Abstract: 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.

Cited by 45 publications

References 5 publications

Advances in patient-controlled analgesia: the role of fentanyl ITS

Advances in patient-controlled analgesia: the role of fentanyl ITS

High Body Mass Index and Use of Fentanyl Iontophoretic Transdermal System in Postoperative Pain Management: Results of a Pooled Analysis of Six Phase 3/3B Trials

Turning Theory into Practice: The Development of Modern Transdermal Drug Delivery Systems and Future Trends

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