Patient-controlled analgesia: A randomized multicenter trial comparing the safety and efficacy of a patient-controlled transdermal fentanyl HCl delivery system versus an intravenous patient-controlled morphine pump for the treatment of acute post-operative pain

Abstract

Intravenous administration of morphine via patient-controlled analgesia (IV PCA) devices is a common method of managing acute postoperative pain. The fentanyl HCl patient-controlled transdermal system (PCTS) is a non-invasive, credit card-sized system using the E-TRANS® delivery platform (ALZA Corp.) that can be applied to the upper arm or chest. This randomized, multicenter study compared the safety and efficacy of these two pain control modalities. After major surgical procedures, 636 adults were titrated to comfort with opioids and randomized 1:1 to fentanyl HCl PCTS or IV PCA morphine. Fentanyl HCl PCTS delivered 40 μg fentanyl on demand, up to 6 doses/hour. The IV PCA delivered 1 mg morphine, up to 10 mg/hour. Visual Analog Scale (VAS) pain intensity scores were recorded before randomization and thereafter for 72 hours. The primary efficacy endpoint was the proportion of patients who rated their method of pain control as excellent or good during the first 24 hours (patient global assessment-PGA). Investigator global assessments, withdrawal due to inadequate analgesia, withdrawal for any reason, and last pain intensity score were also recorded. Demographic data was similar between groups. PGA was comparable between groups, with 233/316 (73.7%) patients receiving fentanyl HCl PCTS rating their method of pain control as excellent or good, compared with 246/320 (76.9%) IV PCA morphine patients.. All secondary efficacy endpoints had comparable outcomes between groups. One occurrence of respiratory depression was reported (in the IV PCA morphine group). The most frequent systemic adverse events in both groups were headache, nausea, pruritus, vomiting, constipation, and dizziness. Mild, self-limiting erythema at the application site was observed in 54% of patients receiving fentanyl HCl PCTS. Fentanyl HCl PCTS, a non-invasive patient-controlled fentanyl HCl system, provided control of acute post-operative pain similar to standard IV PCA morphine. Fentanyl HCl PCTS was well tolerated. Intravenous administration of morphine via patient-controlled analgesia (IV PCA) devices is a common method of managing acute postoperative pain. The fentanyl HCl patient-controlled transdermal system (PCTS) is a non-invasive, credit card-sized system using the E-TRANS® delivery platform (ALZA Corp.) that can be applied to the upper arm or chest. This randomized, multicenter study compared the safety and efficacy of these two pain control modalities. After major surgical procedures, 636 adults were titrated to comfort with opioids and randomized 1:1 to fentanyl HCl PCTS or IV PCA morphine. Fentanyl HCl PCTS delivered 40 μg fentanyl on demand, up to 6 doses/hour. The IV PCA delivered 1 mg morphine, up to 10 mg/hour. Visual Analog Scale (VAS) pain intensity scores were recorded before randomization and thereafter for 72 hours. The primary efficacy endpoint was the proportion of patients who rated their method of pain control as excellent or good during the first 24 hours (patient global assessment-PGA). Investigator global assessments, withdrawal due to inadequate analgesia, withdrawal for any reason, and last pain intensity score were also recorded. Demographic data was similar between groups. PGA was comparable between groups, with 233/316 (73.7%) patients receiving fentanyl HCl PCTS rating their method of pain control as excellent or good, compared with 246/320 (76.9%) IV PCA morphine patients.. All secondary efficacy endpoints had comparable outcomes between groups. One occurrence of respiratory depression was reported (in the IV PCA morphine group). The most frequent systemic adverse events in both groups were headache, nausea, pruritus, vomiting, constipation, and dizziness. Mild, self-limiting erythema at the application site was observed in 54% of patients receiving fentanyl HCl PCTS. Fentanyl HCl PCTS, a non-invasive patient-controlled fentanyl HCl system, provided control of acute post-operative pain similar to standard IV PCA morphine. Fentanyl HCl PCTS was well tolerated.