Acute Pain
Volume 10, Issue 2 , Pages 83-91 , June 2008

IONSYS™ versus morphine PCA: Analysis of the current literature using a Bayesian approach

Received 20 December 2007 ,Revised 21 March 2008 ,Accepted 23 March 2008.

References 

  1. U.S. Food and Drug Administration (FDA): http://www.fda.gov/cder/foi/label/2006/021338lbl.pdf.
  2. European Medicines Agency (EMEA): http://www.emea.europa.eu/humandocs/PDFs/EPAR/ionsys/061206en1.pdf.
  3. Siegel JP. Equivalence and noninferiority trials. Am Heart J. 2000;139:166–170
  4. Kaul S, Diamond GA. Good Enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006;145:62–69
  5. Diamond GA, Kaul S. An Orwellian discourse on the meaning and measurement of noninferiority. Am J Cardiol. 2007;99:284–287
  6. Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence?. Ann Intern Med. 2000;132:715–722
  7. Simon R. Bayesian design and analysis of active control clinical trials. Biometrics. 1999;55:484–487
  8. Diamond GA, Kaul S. Prior convictions: Bayesian approaches to the analysis and interpretation of clinical megatrials. J Am Coll Cardiol. 2004;43:1929–1939
  9. Viscusi ER, Reynolds L, Chung F, Atkinson LE, Khanna S. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain. A randomized controlled trial. JAMA. 2004;291:1333–1341
  10. Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. 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;8:657–668
  11. Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. 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;31:546–554
  12. Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007;98:806–815
  13. Viscusi ER, Siccardi M, Damaraju CV, Hewitt DJ, Kershaw P. 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;105:1428–1436
  14. Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebocontrolled trial. Anesth Analg. 2004;98:427–433
  15. Viscusi ER, Reynolds L, Tait S, Melson T, Irani H, Atkinson LE. An iontophoretic fentanyl patient-controlled analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006;102:188–194
  16. Burton PR, Gurrin LC, Campbell MJ. Clinical significance not statistical significance: a simple Bayesian alternative to p value. J Epidemiol Community Health. 1998;52:318–323
  17. Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR. Bayesian methods in health technology assessment: a review. Health Technol Assess. 2000;4:1–130
  18. Levine JD, Gordon NC, Smith R, Fields HL. Analgesic responses to morphine and placebo in individuals with postoperative pain. Pain. 1981;10:379–389
  19. Diamond GA, Kaul S. Prior convictions: Bayesian approaches to the analysis and interpretation of clinical megatrials. JACC. 2004;43:1929–1939

PII: S1366-0071(08)00079-X

doi: 10.1016/j.acpain.2008.03.003

Acute Pain
Volume 10, Issue 2 , Pages 83-91 , June 2008

Article Tools

* Image Usage & Resolution