An iontophoretic, fentanyl HCl patient-controlled transdermal system for acute postoperative pain management

Patient-controlled modalities using intravenous or epidural routes have dramatically improved postoperative pain management. However, acute post-operative pain continues to be undermanaged. Intravenous patient-controlled analgesia (PCA), the current standard of care for acute postoperative pain management, requires the patient to be attached to a staff-programmed pump apparatus via an intravenous catheter and tubing, rendering it invasive and mobility-limiting. An innovative, needle-free, iontophoretic, fentanyl HCl patient-controlled transdermal system (PCTS) is being developed for acute postoperative pain management. Fentanyl HCl PCTS is a compact, self-contained system that is easily applied to the upper outer arm or chest. It provides pain relief therapeutically equivalent to that of a standard regimen of morphine intravenous PCA, with pharmacokinetics similar to those of intravenous fentanyl infusion. Fentanyl HCl PCTS may be an effective, non-invasive alternative to currently available PCA modalities.

[1]  R. Nirschl,et al.  Iontophoretic Administration of Dexamethasone Sodium Phosphate for Acute Epicondylitis: A Randomized, Double-Blinded, Placebo-Controlled Study , 2003, The American journal of sports medicine.

[2]  Y. Kalia,et al.  Non‐invasive assessment of the effects of iontophoresis on human skin in‐vivo , 2001, The Journal of pharmacy and pharmacology.

[3]  Kenzo Kiikuni,et al.  Improving the Quality of Health care , 1996 .

[4]  G. Kearns,et al.  Percutaneous lidocaine administration via a new iontophoresis system in children: tolerability and absence of systemic bioavailability. , 2003, Pediatrics.

[5]  H. Turndorf,et al.  Satisfaction with epidural and intravenous patient-controlled analgesia. , 2001, Pain medicine.

[6]  J. Apfelbaum,et al.  Practice Guidelines for Acute Pain Management in the Perioperative Setting: An Updated Report by the American Society of Anesthesiologists Task Force on Acute Pain Management , 2004, Anesthesiology.

[7]  J. Chelly,et al.  The Safety and Efficacy of a Fentanyl Patient-Controlled Transdermal System for Acute Postoperative Analgesia: A Multicenter, Placebo-Controlled Trial , 2004, Anesthesia and analgesia.

[8]  K. Zomorodi,et al.  The Effect of Dosing Frequency on the Pharmacokinetics of a Fentanyl HCl Patient-Controlled Transdermal System (PCTS) , 2005, Clinical Pharmacokinetics.

[9]  C. Colwell,et al.  Patient-controlled analgesia compared with intramuscular injection of analgesics for the management of pain after an orthopaedic procedure. , 1995, The Journal of bone and joint surgery. American volume.

[10]  H. Kehlet,et al.  Multimodal Approach to Control Postoperative Pathophysiology and Rehabilitation , 1998, British journal of anaesthesia.

[11]  T. Horlocker Low molecular weight heparin and neuraxial anesthesia. , 2001, Thrombosis research.

[12]  I. Power,et al.  Analgesic agents for the postoperative period. Nonopioids. , 1999, The Surgical clinics of North America.

[13]  M. Ashburn,et al.  Iontophoretic delivery of for postoperative analgesia , 1992 .

[14]  P. Wall,et al.  Pain mechanisms: a new theory. , 1965, Science.

[15]  A. Sandler,et al.  A review of the use of fentanyl analgesia in the management of acute pain in adults. , 1999, Anesthesiology.

[16]  L. Ready,et al.  Acute Pain: Lessons Learned From 25,000 Patients , 1999, Regional Anesthesia & Pain Medicine.

[17]  A. Albert,et al.  Effectiveness of an acute pain service inception in a general hospital. , 1999, Journal of clinical anesthesia.

[18]  D B Carr,et al.  Postoperative patient-controlled analgesia: meta-analyses of initial randomized control trials. , 1993, Journal of clinical anesthesia.

[19]  S. Mehta,et al.  Postoperative Pain Experience: Results from a National Survey Suggest Postoperative Pain Continues to Be Undermanaged , 2003, Anesthesia and analgesia.

[20]  A. Wagstaff,et al.  Transdermal fentanyl: an updated review of its pharmacological properties and therapeutic efficacy in chronic cancer pain control. , 2001, Drugs.

[21]  M. Ashburn,et al.  Iontophoretic delivery of morphine for postoperative analgesia. , 1992, Journal of Pain and Symptom Management.

[22]  P. J.,et al.  Practice Guidelines for Acute Pain Management in the Perioperative Setting: Bibliography American Society of Anesthesiologists , 2002 .

[23]  J. Gross A Cost-Utility and Cost-Effectiveness Analysis of an Acute Pain Service , 2005 .

[24]  T. J. Wasylak,et al.  Reduction of post-operative morbidity following patient-controlled morphine , 1990, Canadian journal of anaesthesia = Journal canadien d'anesthesie.

[25]  R. Jedeikin,et al.  A comparison of three techniques for acute postoperative pain control following major abdominal surgery. , 2003, Journal of clinical anesthesia.

[26]  Kim J. Vicente,et al.  Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability , 2003, Canadian journal of anaesthesia = Journal canadien d'anesthesie.

[27]  G. R. Williams,et al.  Management of perioperative pain in hospitalized patients: a national survey. , 1998, Journal of clinical anesthesia.

[28]  Suneel K. Gupta,et al.  Effects of Application Site and Subject Demographics on the Pharmacokinetics of Fentanyl HCl Patient-Controlled Transdermal System (PCTS) , 2005, Clinical Pharmacokinetics.

[29]  L E Mather,et al.  Variables of patient‐controlled analgesia 1. bolus size , 1989, Anaesthesia.

[30]  John A. Cowan,et al.  Efficacy of postoperative epidural analgesia: a meta-analysis. , 2003, JAMA.

[31]  Suneel K. Gupta,et al.  Characterisation of the Pharmacokinetics of the Fentanyl HCl Patient-Controlled Transdermal System (PCTS) , 2005, Clinical Pharmacokinetics.

[32]  Practice guidelines for acute pain management in the perioperative setting. A report by the American Society of Anesthesiologists Task Force on Pain Management, Acute Pain Section. , 1995, Anesthesiology.

[33]  Medication safety: PCA pump programming errors continue to cause fatal overinfusions. , 2002, Health devices.

[34]  R. Rosenquist,et al.  Regional Anesthesia in the Anticoagulated Patient: Defining the Risks , 2003, Regional Anesthesia & Pain Medicine.

[35]  B. Walder,et al.  Efficacy and safety of patient‐controlled opioid analgesia for acute postoperative pain , 2001, Acta anaesthesiologica Scandinavica.

[36]  F. Chung,et al.  Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. , 2004, JAMA.

[37]  Thomas E. Elliott,et al.  Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain, 4th Edition:The American Pain Society: Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain. 4th edition. , 2000 .

[38]  S. Jacobsen,et al.  Painless cauterization of spider veins with the use of iontophoretic local anesthesia. , 1988, Journal of the American Academy of Dermatology.

[39]  M. Stadler,et al.  A cost-utility and cost-effectiveness analysis of an acute pain service. , 2004, Journal of clinical anesthesia.

[40]  M. Chauvin State of the art of pain treatment following ambulatory surgery. , 2003, European journal of anaesthesiology. Supplement.

[41]  R. Sinatra,et al.  Pain management after major orthopaedic surgery: current strategies and new concepts. , 2002, The Journal of the American Academy of Orthopaedic Surgeons.

[42]  E. Viscusi,et al.  Iontophoresis: The Process Behind Noninvasive Drug Delivery , 2004, Regional Anesthesia & Pain Medicine.

[43]  L. Bertolucci Introduction of Antiinflammatory Drugs by lontophoresis: Double Blind Study. , 1982, The Journal of orthopaedic and sports physical therapy.

[44]  M. Smythe,et al.  Patient-controlled analgesia versus intramuscular analgesic therapy. , 1994, American journal of hospital pharmacy.

[45]  B. W. Barry,et al.  Novel mechanisms and devices to enable successful transdermal drug delivery. , 2001, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[46]  J. Bovill,et al.  Postoperative Analgesic Effects of Three Demand-Dose Sizes of Fentanyl Administered by Patient-Controlled Analgesia , 1998, Anesthesia and Analgesia.

[47]  M. Austrup,et al.  Analgesic agents for the postoperative period. Opioids. , 1999, The Surgical clinics of North America.

[48]  Frances V. Abbott,et al.  Reduction of Postoperative Morbidity Following Patient-Controlled Morphine , 1991 .

[49]  Abbott PCA Plus II patient-controlled analgesic pumps prone to misprogramming resulting in narcotic overinfusions. , 1997, Health devices.

[50]  L. Campbell I.v.-related phlebitis, complications and length of hospital stay: 2. , 1998, British journal of nursing.