Context Patient-controlled analgesia (PCA) with morphine is commonly used to
provide acute postoperative pain control after major surgery. The fentanyl
hydrochloride patient-controlled transdermal system eliminates the need for
venous access and complicated programming of pumps.
Objective To assess the efficacy and safety of an investigational patient-controlled
iontophoretic transdermal system using fentanyl hydrochloride compared with
a standard intravenous morphine patient-controlled pump.
Design, Setting, and Patients Prospective randomized controlled parallel-group trial conducted between
September 2000 and March 2001 at 33 North American hospitals, enrolling 636
adult patients who had just undergone major surgery.
Interventions In surgical recovery rooms, patients were randomly assigned to intravenous
morphine (1-mg bolus every 5 minutes; maximum of 10 mg/h) by a patient-controlled
analgesia pump (n = 320) or iontophoretic fentanyl hydrochloride (40-µg
infusion over 10 minutes) by a patient-controlled transdermal system (n =
316). Supplemental analgesia (morphine or fentanyl intravenous boluses) was
administered as needed before and for the first 3 hours after activation of
the PCA treatments. Patients then used the PCA treatments without additional
analgesics for up to 72 hours.
Main Outcome Measures The primary efficacy variable was patient global assessment of the method
of pain control during the first 24 hours. Additional efficacy measures were
the proportion of patients discontinuing the study because of inadequate analgesia
for any reason, patient-reported pain intensity scores on a 100-mm visual
analog scale (VAS), and patient global assessments at 48 and 72 hours. Adverse
effects were also recorded.
Results Ratings of good or excellent after 24 hours of treatment for the method
of pain control were given by 73.7% of patients (233/316) who used transdermal
fentanyl PCA and 76.9% of patients (246/320) who used intravenous morphine
PCA; treatment difference was –3.2% (95% confidence interval, –9.9%
to 3.5%; P = .36). Early patient discontinuations
(25.9% fentanyl vs 25.0% morphine; P = .78) and last
pain intensity scores (32.7 fentanyl vs 31.1 morphine on the VAS; P = .45) were not different between the 2 treatments. With continued
treatment for up to 48 or 72 hours, more than 80% of patient assessments in
each treatment group were good or excellent. The incidence of opioid-related
adverse events was similar between the groups.
Conclusion An investigational PCA transdermal system using iontophoresis to deliver
fentanyl provided postsurgical pain control equivalent to that of a standard
intravenous morphine regimen delivered by a PCA pump.