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Fentanyl iontophoretic transdermal system versus morphine intravenous patient-controlled analgesia for pain management following orthopedic surgery: A pooled analysis of randomized, controlled trials

Craig T. Hartrick, MD, Donald M. Knapke, MD, Li Ding, MS, MA, Hassan Danesi, MD, James B. Jones, MD

Abstract


Objective: To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (IV) patient-controlled analgesia (PCA).

Setting: Acute Care Hospital.

Patients: Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine IV PCA for postoperative pain in hospitalized postoperative patients. A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment.

Interventions: A total of 590 patients received fentanyl ITS (40 μg/dose) and 626 patients received morphine IV PCA (1 mg/dose) for up to 72 hours.

Main outcome measures: Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control.

Results: Patients had a mean age of about 60 years, were predominantly Caucasian (90.5 percent), and the majority underwent hip replacement (80.3 percent). There were more patients treated with fentanyl ITS who rated their pain control method as “excellent” compared to morphine IV PCA at 24 hours postsurgery (44.8 percent vs 33.0 percent, respectively; p < 0.001), 48 hours (37.5 percent vs 25.3 percent, respectively; p < 0.001), and at the last assessment (54.3 percent vs 39.6 percent, respectively; p < 0.001). There were more investigators who rated treatment with fentanyl ITS as “excellent” compared to morphine IV PCA at the last assessment (57.4 percent vs 36.9 percent, respectively; p < 0.001).

Conclusions: Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as “excellent” on the PGA and IGA assessments with fentanyl ITS than with morphine IV PCA.


Keywords


fentanyl, morphine, patient-controlled analgesia, iontophoretic transdermal system, postoperative pain

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References


Costantini R, Affaitati G, Fabrizio A, et al.: Controlling pain in the post-operative setting. Int J Clin Pharmacol Ther. 2011; 49(2): 116-127.

Pasero C: Safe IV opioid titration in patients with severe acute pain. J Perianesth Nurs. 2010; 25(5): 314-318.

Binning AR, Przesmycki K, Sowinski P, et al.: A randomized controlled trial on the efficacy and side-effect profile (nausea/vomiting/sedation) of morphine-6-glucuronide versus morphine for post-operative pain relief after major abdominal surgery. Eur J Pain. 2011; 15(4): 402-408.

Wilkinson J, Pennefather SH, McCahon RA: Thoracic Anaesthesia. New York: Oxford University Press, 2011: 704.

West DD: The role of patient-controlled analgesia in postoperative pain management. Physician Assist. 1990; 14(12): 21-24.

Smythe M: Patient-controlled analgesia: A review. Pharmacotherapy. 1992; 12(2): 132-143.

Hudcova J, McNicol E, Quah C, et al.: Patient controlled opioid analgesia versus conventional opioid analgesia for postoperative pain. Cochrane Database Syst Rev. 2006; 4: CD003348.

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, table of contents.

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.

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.

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.

Viscusi ER, Reynolds L, Tait S, et al.: An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: A double-blind, placebo-controlled trial. Anesth Analg. 2006; 102(1): 188-194.

Rothman M, Vallow S, Damaraju CV, et al.: Using the patient global assessment of the method of pain control to assess new analgesic modalities in clinical trials. Curr Med Res Opin. 2009; 25(6): 1433-1443.

Schein JR, Hicks RW, Nelson WW, et al.: Patient-controlled analgesia-related medication errors in the postoperative period: Causes and prevention. Drug Saf. 2009; 32(7): 549-559.

Hicks RW, Sikirica V, Nelson W, et al.: Medication errors involving patient-controlled analgesia. Am J Health Syst Pharm. 2008; 65(5): 429-440.

Markey DW, Brown RJ: An interdisciplinary approach to addressing patient activity and mobility in the medical-surgical patient. J Nurs Care Qual. 2002; 16(4): 1-12.




DOI: https://doi.org/10.5055/jom.2016.0310

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