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

Leopold Eberhart, MD

doi:10.5055/jom.2007.0012

Authors

Leopold Eberhart, MD

DOI:

https://doi.org/10.5055/jom.2007.0012

Keywords:

fentanyl, iontophoresis, patient-controlled analgesia, postoperative pain

Abstract

Background and objective: 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.
Methods: Data were pooled from three placebocontrolled 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.
Results: 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 (≥65 years of age) and patients <65 years of age.
Conclusion: The fentanyl ITS addresses certain safety issues of existing modalities while providing comparable pain relief, making it an attractive option for postoperative pain management.

Author Biography

Leopold Eberhart, MD

Department of Anaesthesiology and Intensive Care, Philipps-University, Marburg, Germany.

References

Apfelbaum JL, Chen C, Mehta SS, et al.: Postoperative pain experience: Results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003; 97: 534-540.

Chauvin M: State of the art of pain treatment following ambulatory surgery. Eur J Anaesthesiol. 2003; 20(suppl 28): 3-6.

Shang AB, Gan TJ: Optimising postoperative pain management in the ambulatory patient. Drugs. 2003; 63: 855-867.

Rawal N: Treating postoperative pain improves outcome. Minerva Anestesiol. 2001; 67: 200-205.

Summers S: Evidence-based practice part 3: Acute pain management of the perianesthesia patient. J PeriAnesth Nurs. 2001; 16: 112-120.

Kehlet H: Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997; 78: 606-617.

Bertolini G, Minelli C, Latronico N, et al.: The use of analgesic drugs in postoperative patients: The neglected problem of pain control in intensive care units. An observational, prospective, multicenter study in 128 Italian intensive care units. Eur J Clin Pharmacol. 2002; 58: 73-77.

Dolin SJ, Cashman JN, Bland JM: Effectiveness of acute postoperative pain management. I. Evidence from published data. Br J Anaesth. 2002; 89: 409-423.

International Association of the Study of Pain: Task force on acute pain. In Ready LB, Edwards WT (eds.): Management of Acute Pain: A Practical Guide. Seattle, WA: IASP Press, 1992.

Francesca F, Bader P, Echtle D, et al.: European Association of Urology guidelines on pain management. Eur Urol. 2003; 44: 383-389.

Nolli M, Nicosia F: Postoperative pain management. Aims and organization of a strategy for postoperative acute pain therapy [in Italian]. Minerva Anestesiol. 2000; 66: 585-601.

McDonnell A, Nicholl J, Read SM: Acute Pain Teams in England: Current provision and their role in postoperative pain management. J Clin Nurs. 2003; 12: 387-393.

Stamer U, Mpasios N, Stuber F, et al.: Postoperative pain therapy in Germany [in German]. Anaesthesist. 2002; 51: 248-257.

Stomberg MW, Wickstrom K, Joelsson H, et al.: Postoperative pain management on surgical wards–Do quality assurance strategies result in long-term effects on staff member attitudes and clinical outcomes? Pain Manag Nurs. 2003; 4: 11-22.

Rawal N, Allvin R: Acute pain services in Europe: A 17- nation survey of 105 hospitals. The EuroPain Acute Pain Working Party. Eur J Anaesthesiol. 1998; 15: 354-363.

Jiang HJ, Lagasse RS, Ciccone K, et al.: Factors influencing hospital implementation of acute pain management practice guidelines. J Clin Anesth. 2001; 13: 268-276.

Schafheutle EI, Cantrill JA, Noyce PR: Why is pain management suboptimal on surgical wards? J Adv Nurs. 2001; 33: 728-737.

Jin F, Chung F: Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001; 13: 524-539.

Skinner HB: Multimodal acute pain management. Am J Orthop. 2004; 33: 5-9.

Hartrick CT: Multimodal postoperative pain management. Am J Health Syst Pharm. 2004; 61(suppl 1): S4-S10.

Flouvat B, Leneveu A, Fitoussi S, et al.: Bioequivalence study comparing a new paracetamol solution for injection and propacetamol after single intravenous infusion in healthy subjects. Int J Clin Pharmacol Ther. 2004; 42: 50-57.

Sinatra RS, Torres J, Bustos AM: Pain management after major orthopaedic surgery: Current strategies and new concepts. J Am Acad Orthop Surg. 2002; 10: 117-129.

Austrup ML, Korean G: Analgesic agents for the postoperative period. Opioids. Surg Clin North Am. 1999; 79: 253-273.

Chen PP, Chui PT, Ma M, et al.: A prospective survey of patients after cessation of patient-controlled analgesia. Anesth Analg. 2001; 92: 224-227.

Vicente KJ, Kada-Bekhaled K, Hillel G, et al.: Programming errors contribute to death from patient-controlled analgesia: Case report and estimate of probability. Can J Anaesth. 2003; 50: 328-332.

Ready LB: Acute pain: Lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999; 24: 499-505.

Ballantyne JC, Carr DB, Chalmers TC, et al.: Postoperative patient-controlled analgesia: Meta-analyses of initial randomized control trials. J Clin Anesth. 1993; 5: 182-193.

Chumbley GM, Hall GM, Salmon P: Why do patients feel positive about patient-controlled analgesia? Anaesthesia. 1999; 54: 386-389.

Chelly JE, Grass J, Houseman TW, et al.: The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: A multicenter, placebo-controlled trial. Anesth Analg. 2004; 98: 427-433.

Viscusi ER, Reynolds L, Tait S, et al.: An iontophoretic fentanyl patient-controlled analgesic delivery system for postoperative pain: A double-blind, placebo-controlled trial. Anesth Analg. 2006; 102: 188-194.

Brown CR, Moodie JE, Bisley EJ: Safety and efficacy of Transfenta in the treatment of post-operative pain: A doubleblind, single-center, placebo-controlled trial. Presented at the 17th Annual Scientific Meeting of the American Pain Society, November 5-8, 1998, San Diego, California.

Viscusi ER, Reynolds L, Chung F, et al.: Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: A randomized controlled trial. JAMA. 2004; 291: 1333-1341.

Dolin SJ, Cashman JN: Tolerability of acute postoperative pain management: Nausea, vomiting, sedation, pruritis, and urinary retention. Evidence from published data. Br J Anaesth. 2005; 95: 584-591.

Boogaerts JG, Vanacker E, Seidel L, et al.: Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000; 44: 470-474.

Eberhart LH, Morin AM, Felbinger TW, et al.: Results of a survey of anesthetists on postoperative nausea and vomiting. Anasthesiol Intensivmed Notfallmed Schmerzther. 1998; 33: 545-551.

Cashman JN, Dolin SJ: Respiratory and haemodynamic effects of acute postoperative pain management: Evidence from published data. Br J Anaesth. 2004; 93: 212-223.

Walder B, Schafer M, Henzi I, et al.: Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001; 45: 795-804.

Kalkman CJ, Visser K, Moen J, et al.: Preoperative prediction of severe postoperative pain. Pain. 2003; 105: 415-423.