Safety and tolerability of fentanyl iontophoretic transdermal system: Findings from a pooled data analysis of four clinical trials
DOI:
https://doi.org/10.5055/jom.2010.0018Keywords:
tolerability, pain management, postoperative, fentanyl ITS, patient-controlled analgesiaAbstract
Acute postoperative pain remains inadequately managed. Although patientcontrolled 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 pain 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 1,288 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.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(2): 534-540.
Cavalieri TA: Pain management in the elderly. J Am Osteopath Assoc. 2002; 102(9): 481-485.
Wilder-Smith OH: Opioid use in the elderly. Eur J Pain. 2005; 9(2): 137-140.
Davis MP, Srivastava M: Demographics, assessment and management of pain in the elderly. Drugs Aging. 2003; 20(1): 23-57.
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(7): 795-804.
Ballantyne JC, Carr DB, Chalmers TC, et al.: Postoperative patient-controlled analgesia: Meta-analyses of initial randomized control trials. J Clin Anesth. 1993; 5(3): 182-193.
Colwell CW Jr, Morris BA: Patient-controlled analgesia compared with intramuscular injection of analgesics for the management of pain after an orthopaedic procedure. J Bone Joint Surg Am. 1995; 77(5): 726-733.
Carr DB, Reines HD, Schaffer J, et al.: The impact of technology on the analgesic gap and quality of acute pain management. Reg Anesth Pain Med. 2005; 30(3): 286-291.
Wasylak TJ, Abbott FV, English MJM, et al.: Reduction of post-operative morbidity following patient-controlled morphine. Can J Anaesth. 1990; 37(7): 726-731.
Smythe M, Loughlin K, Schad RF, et al.: Patient-controlled analgesia versus intramuscular analgesic therapy. Am J Hosp Pharm. 1994; 51(11): 1433-1440.
Lebovits AH, Zenetos P, O’Neill DK, et al.: Satisfaction with epidural and intravenous patient-controlled analgesia. Pain Med. 2001; 2(4): 280-286.
Viscusi ER, Witkowski TA: Iontophoresis: The process behind noninvasive drug delivery. Reg Anesth Pain Med. 2005; 30: 292-294.
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(2): 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(1): 188-194.
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(11): 1333-1341.
Hartrick CT, Bourne MH, Gargiulo K, et al.: Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: A comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006; 31(6): 546-554.
Minkowitz HS, Rathmell JP, Vallow S, et al.: 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. Pain Med. 2007; 8(8): 657-668.
Grond S, Hall J, Spacek A, et al.: Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007; 98(6): 806-815.
Viscusi ER, Siccardi M, Damaraju CV, et al.: The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: An analysis of pooled data from three randomized, active-controlled clinical studies. Anesth Analg. 2007; 105(5): 1428-1436.
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(5): 584-591.
Wheeler M, Oderda GM, Ashburn MA, et al.: Adverse events associated with postoperative opioid analgesia: A systematic review. J Pain. 2002; 3(3): 159-180.
Fleming BM, Coombs DW: A survey of complications documented in a quality-control analysis of patient-controlled analgesia in the postoperative patient. J Pain Symptom Manage. 1992; 7(8): 463-469.
Schug SA, Torrie JJ: Safety assessment of postoperative pain management by an acute pain service. Pain. 1993; 55(3): 387-391.
Etches RC: Respiratory depression associated with patient-controlled analgesia: A review of eight cases. Can J Anaesth. 1994; 41(2): 125-132.
Sidebotham D, Dijkhuizen MR, Schug SA: The safety and utilization of patient-controlled analgesia. J Pain Symptom Manage. 1997; 14(4): 202-209.
Clark AJ, Ahmedzai SH, Allan LG, et al.: Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. Curr Med Res Opin. 2004; 20(9): 1419-1428.
Eisenstaedt R, Penninx BW, Woodman RC: Anemia in the elderly: Current understanding and emerging concepts. Blood Rev. 2006; 20(4): 213-226.
Doyle DJ, Vicente KJ: Electrical short circuit as a possible cause of death in patients on PCA machines: Report on an opiate overdose and a possible preventive remedy. Anesthesiology. 2001; 94(5): 940.
Doyle DJ: Programming errors from patient-controlled analgesia. Can J Anaesth. 2003; 50(8): 855-856.
Williams MA, MacKrodt K: A faulty PCA device. Anaesthesia. 2001; 56(4): 391-392.
Kluger MT, Owen H: Patient-controlled analgesia: Can it be made safer? Anaesth Intensive Care. 1991; 19(3): 412-420.
Wilburn SQ: Needlestick and sharps injury prevention. Online J Issues Nurs. 2004; 9(3): 5.
Published
How to Cite
Issue
Section
License
Copyright 2005-2024, Weston Medical Publishing, LLC
All Rights Reserved
