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LETTERS TO THE EDITOR

The Quest for New Devices to Improve Postoperative Pain Control

Department of Anesthesiology, University Hospital Maastricht, Maastricht, The Netherlands

To the Editor:

I wish to congratulate the authors for their study on the safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia (1). However, their conclusion that fentanyl HCL PCTS 40 µg was superior to placebo for the management of acute postoperative pain control is optimistic. When you look at the VAS scores, there seem to be no major differences between the two groups. But a major drawback in this study is the matching of the placebo and treatment group. When you use a 3:1 ratio of patients treated to patients not treated you expect a group that is well matched. However, a clear definition of patients included in the two groups was not given. Because various operations were included (abdominal, orthopedic, or thoracic surgery) and a precise definition of pain was not given (expected to have moderate to severe pain requiring parenteral opioids), it is difficult to compare the two groups.

The only thing we can conclude from this study is that there might be a better way to treat patients postoperatively. It may be argued that the skin is not the optimal barrier to conquer in order to get an optimal pain relief postoperatively. There are other delivery systems for other surfaces to get better pain relief, such as the nasal or oral mucosa. Even implantable devices or wound catheters could be candidates for postoperative pain relief.

Reference

1. 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: 427–33.[Abstract/Free Full Text]

Response

Professor of Anesthesiology and Orthopedic Surgery, Director of Orthopedic Anesthesia and Acute Pain, Vice Chair of Clinical Research, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA

In Response:

We would like to address the comments of Marcus et al. regarding our recently published article. Our results demonstrated not only that a larger proportion of patients in the placebo group withdrew from the study due to inadequate pain control, but also that the mean last pain intensity scores of placebo patients were significantly higher than those in the active treatment group (40.8 vs 30.9, respectively, P = 0.0474) (1). The superior efficacy of fentanyl HCl patient-controlled transdermal system (PCTS) compared with placebo has recently been confirmed in a large randomized, controlled trial (2).

The 3:1 randomization in our trial was chosen to decrease the exposure to placebo of postsurgical patients undergoing major surgery. This is a perfectly accepted design.

As for as the comment related to the best barrier for delivering fentanyl, this is really outside of the scope of our study. In addition, Marcus and colleagues may want to recognize that our paper was about a patient-controlled system. Such a concept would be, at the very least, very difficult to apply to either an intranasal or an oral mucosa route.

References

1. Chelly JE, Grass J, Houseman TW, et al. The safety and efficacy of a patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg 2004; 98: 427–33.
2. Viscusi E, Reynolds L, Tait S, Melson T, Irani H. Evaluation of a needle-free, transdermal, patient-controlled analgesic delivery system for the treatment of acute postoperative pain: a double-blind, multicenter, placebo-controlled trial incorporating JCAHO pain management standards (abstract A-993). Presented at the American Society of Anesthesiologists Annual Meeting, October 11–15, 2003, San Francisco, CA.

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