Patient-controlled analgesia: A double-blind, multicenter, placebo-controlled trial incorporating the JCAHO pain management standards in the evaluation of a patient-controlled transdermal fentanyl delivery system for acute postoperative pain management

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The undertreatment of pain is recognized as a major public health problem, and JCAHO standards were developed in response to this issue. These standards may be applied when evaluating innovative pain management systems, such as the fentanyl HCl patient-controlled transdermal system (PCTS), a needle-free, credit card-sized system designed to be applied to the upper arm or chest. This study compared its safety and efficacy with placebo for acute postoperative pain. Patients were randomized 1:1 to receive fentanyl HCl PCTS 40 μg or placebo systems for 24 hours post-surgery. Pursuant to JCAHO standards, patients were educated regarding postoperative pain, pain assessment, and goals of pain control prior to and after surgery. The primary efficacy parameter was the percentage of patients discontinuing because of inadequate pain control three or more hours after system application. Pain intensity, patient global assessment (PGA), investigator global assessment (IGA), patient satisfaction, ease of use, and convenience were also evaluated. 244 subjects were randomized to fentanyl HCl PCTS, and 240 to placebo. Significantly fewer patients on fentanyl HCl PCTS discontinued due to inadequate analgesia compared to placebo (28.7% versus 60.0%; P<0.0001), and last pain intensity score was 3.5 (fentanyl HCl PCTS) versus 5.4 (placebo). A majority of fentanyl HCl PCTS patients (65%) met or exceeded their pain management goal versus placebo (37%; P<0.001). Patients (76.2%, PGA) and investigators (74.9%, IGA) also considered the fentanyl HCl PCTS a good or excellent method of pain control, and 64% of patients receiving the active treatment were very satisfied with the system versus 37% on placebo (P<0.001). Study medication was well tolerated. The fentanyl HCl PCTS 40 mcg was superior to placebo for patient-controlled analgesia after major surgery and was well tolerated. Patients considered fentanyl HCl PCTS convenient and easy to use.