Postoperative Pain Management With a Patient-Controlled Transdermal Delivery System for Fentanyl

Peter J. S. Koo

Disclosures

Am J Health Syst Pharm. 2005;62(11):1171-1176. 

In This Article

Efficacy and Safety

A randomized trial comparing fentanyl hydrochloride PCTS with placebo in 189 patients who had undergone major surgery found that significantly fewer patients receiving PCTS withdrew from the trial because of inadequate analgesia (25.4% of PCTS recipients versus 40.4% of placebo recipients [ p < 0.05]).[32] After three hours of treatment, the cumulative percentage of patients who withdrew for this reason was higher for placebo recipients than for PCTS-treated patients for the remainder of the trial. Mean ± S.E. pain intensity scores measured with a visual-analogue scale (VAS) on which 0 represented no pain and 100 worst possible pain were significantly lower at the last patient observation for PCTS-treated patients than for placebo recipients (30.9 ± 2.4 versus 40.8 ± 4.6, respectively, with pain scores unavailable for 31 patients [ p = 0.047]). In addition, patients treated with PCTS were more satisfied with their pain control than those given placebo, as assessed on a scale from 1 (poor control) to 4 (excellent control) (3.0 versus 2.6, respectively [ p = 0.047]). While this study yielded promising results, limitations included the potential bias introduced by the 3:1 randomization scheme and the lack of control for pain level upon study entry.

In a larger ( n = 439) randomized trial, significantly fewer PCTS-treated than placebo-treated patients discontinued participation because of inadequate pain relief (27.2% versus 56.9%, respectively [ p < 0.001]).[33] Mean VAS scores at the final patient observation were significantly lower for PCTS-treated patients than for those who received placebo. Significantly more patients treated with PCTS met or exceeded their pain management goals (65%) than did those treated with placebo (37%) ( p < 0.001). Other secondary efficacy endpoints confirmed the superiority of PCTS over placebo ( Table 3 ). One study limitation is that a comparison with placebo does not represent the "real world" of acute pain management. In addition, supplemental analgesic medication was not allowed after three hours of study treatment, which again may not align with day-to-day clinical practice, given the increasing use of multimodal analgesia postoperatively.

In a third randomized controlled trial, PCTS was equianalgesic to i.v. PCA (morphine) in 636 patients who had undergone major surgery, including abdominal, orthopedic, and thoracic procedures.[34] Pain control after 24 hours of treatment was rated good or excellent by 73.7% and 76.9% of patients treated with PCTS and PCA, respectively ( p = 0.36). Discontinuation rates due to inadequate analgesia were similar between groups (15.2% for PCTS and 10.3% for PCA [ p = 0.07]), as were mean ± S.E. VAS scores at the final patient visit (32.7 ± 1.6 for PCTS versus 31.1 ± 1.5 for PCA [ p = 0.45]). Nausea was common in both groups (40.8% and 45.9% for PCTS and PCA, respectively), as were fever (20.9% for PCTS, 20.3% for PCA) and headache (14.9% for PCTS, 9.1% for PCA). In all of these trials, application-site reactions in PCTS-treated patients, most commonly mild to moderate erythema, were self-limiting and resolved without treatment. No episodes of clinically relevant respiratory depression were reported with PCTS use. This study addressed one major limitation of the previously described studies by including an active treatment rather than placebo for comparison with PCTS. The results not only corroborate the efficacy data from the other trials but also indicate that PCTS is comparable in efficacy and safety to PCA with morphine, which is currently one of the most widely used modalities for postoperative pain control.

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