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Fentanyl HCl iontophoretic transdermal system versus intravenous morphine pump after gynecologic surgery

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Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Objective

To compare the efficacy and safety of fentanyl iontophoretic transdermal system (ITS) with morphine intravenous patient-controlled analgesia (IV PCA) for pain management following gynecologic surgery.

Method

A subgroup (n = 275) of gynecologic surgery patients from a randomized study (N = 636) of patients treated with fentanyl ITS or morphine IV PCA was analyzed. The main efficacy endpoint was the patient global assessment (PGA) of the method of pain control (first 24 h).

Result

In gynecologic surgery patients, PGA success ratings (excellent/good) were statistically equivalent (fentanyl ITS, 84.8%; morphine IV PCA, 83.9%; 95% confidence interval: -7.7%, 9.4%) based on the prespecified equivalence criterion of 10% for the entire study population. Pain intensity at 3 h (P = 0.296), discontinuations due to inadequate analgesia (P = 0.148), and percentages of patients requesting supplemental opioids in the first 3 h (P = 0.524) were similar.

Conclusion

The two modalities were therapeutically equivalent for pain management in these gynecologic surgery patients.

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Acknowledgments

The authors wish to acknowledge the investigators who contributed participants to this subgroup analysis: Raymond L. Brewer, MD, Rose Medical Group, University City, Texas; A. John Clark, MD, FRCPC, Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia; Craig S. Curry, MD, Maine Medical Center, Portland, Maine; Robert B. Fisher, DO, University of Missouri, Columbia, Missouri; Brian Ginsberg, MD, Duke University Medical Center, Durham, North Carolina; Michael E. Goldberg, MD, Cooper Hospital, Camden, New Jersey; Daniel E. Kenady, MD, University of Kentucky Medical Center, Lexington, Kentucky; Samia Khalil, MD, University of Texas Medical School, Houston, Texas; Anthony L. Kovac, MD, University of Kansas Medical Center, Kansas City, Kansas; Cynthia Lien, MD, New York Presbyterian Hospital, New York, New York; Timothy Lubenow, MD, Rush-Presbyterian-St Luke’s Medical Center, Chicago, Illinois; Tim Melson, MD, Helen Keller Hospital, Sheffield, Alabama; Harold S. Minkowitz, MD, Memorial Hermann Memorial City Hospital, Houston, Texas; Joel L. Parlow, MD, Queens University, Kingston General Hospital, Kingston, Ontario, Canada; Lowell Reynolds, MD, Loma Linda University, Loma Linda, California; Adam Sackstein, MD, St Francis Medical Center, Trenton, New Jersey; Jeffrey H. Silverstein, MD, Mount Sinai School of Medicine, New York, New York; Daneshvari Solanki, MD, University of Texas, Galveston, Texas; Robert Steinberg, MD, PhD, Baystate Medical Center, Springfield, Massachusetts; Eugene R. Viscusi, MD, Thomas Jefferson University, Philadelphia, Pennsylvania; Barth L. Wilsey, MD, University of California, Davis, California; Joel Yarmush, MD, MPA, New York Methodist Hospital, Brooklyn, New York.

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Authors and Affiliations

  1. Department of Anesthesiology, Northwestern University Feinberg School of Medicine, 251 E. Huron Street, F5-704, Chicago, IL, 60611, USA

    Shireen Ahmad

  2. Ortho-McNeil, Inc., Raritan, NJ, USA

    David J. Hewitt

  3. Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ, USA

    C. V. Damaraju

Authors
  1. Shireen Ahmad
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  2. David J. Hewitt
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  3. C. V. Damaraju
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Corresponding author

Correspondence to Shireen Ahmad.

Additional information

ALZA Corporation, Mountain View, CA, supported this study in its entirety. Dr Hewitt is an employee of Ortho-McNeil, Inc. Dr Damaraju is an employee of Ortho-McNeil Janssen Scientific Affairs, LLC.

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Ahmad, S., Hewitt, D.J. & Damaraju, C.V. Fentanyl HCl iontophoretic transdermal system versus intravenous morphine pump after gynecologic surgery. Arch Gynecol Obstet 276, 251–258 (2007). https://doi.org/10.1007/s00404-007-0339-z

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  • DOI: https://doi.org/10.1007/s00404-007-0339-z

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