Transdermal fentanyl for postoperative pain management. A double-blind placebo study.

A double-blind, placebo-controlled, randomized design was used to evaluate the safety and efficacy of transdermal fentanyl citrate for postoperative pain management in 42 healthy adult patients undergoing major shoulder surgery. Transdermal systems rated to deliver fentanyl citrate at a rate of 75 micrograms/h were applied to the skin immediately prior to surgery and worn for 24 hours. Patients in the active group required significantly less morphine than the placebo group during the 24-hour period that systems were in place (0.8 +/- 0.61 vs 1.3 +/- 0.64 mg/h) and for the first 12 hours after removal (0.3 +/- 0.36 vs 0.5 +/- 0.32 mg/h). The incidence of vomiting was more frequent in the active group than in the placebo group (73% vs 30%), and respiratory rate in the active group was lower than in the placebo group during the 13- to 24-hour interval of system application (14 +/- 3 vs 16 +/- 2 breaths per minute). Nevertheless, transdermal fentanyl appears to be safe and effective after orthopedic surgery in healthy adult patients.