Intravenous acetaminophen, 1 g, administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective analgesia and was well tolerated.

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 patientcontrolled 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.

An iontophoretic fentanyl HCl patient-activated transdermal system (fentanyl HCl PATS) is under development for the treatment of acute postoperative pain. The fentanyl HCl PATS is a needle-free, credit card-sized, preprogrammed system that is applied to the patient's upper outer arm or chest. The fentanyl HCl PATS was demonstrated to be superior to placebo in a previous trial; however, the randomization scheme used and the lack of control of entry pain level may have contributed to the lack of robust findings. We compared the fentanyl HCl PATS with placebo for acute postoperative pain management in a larger trial that addressed the limitations of the previous study. Adult patients admitted to the postanesthesia care unit after major surgery were titrated to comfort with opioids and randomized 1:1 to receive the fentanyl HCl PATS 40 microg or placebo for 24 hours. Supplemental IV fentanyl was available to patients upon request in both treatment groups for the first 3 hours after enrollment. The primary efficacy end-point was the percentage of patients who discontinued participation in the study because of inadequate analgesia. Pain intensity scores, patient global assessments (PGA), and investigator global assessments (IGA) were collected. Four-hundred-eighty-four patients (PATS, n = 244; placebo, n = 240) were enrolled. Fewer patients receiving the fentanyl HCl PATS discontinued because of inadequate analgesia compared with placebo (28.7% versus 60.0%; P < 0.0001). Mean last pain intensity scores were 3.5 and 5.4 for the fentanyl HCl PATS and placebo groups, respectively. Patients (73.4%, PGA) and investigators (72.1%, IGA) considered the fentanyl HCl PATS a good or excellent method of pain control. Treatment-related adverse events were similar between groups. This study demonstrated the superiority of the iontophoretic fentanyl HCl PATS over placebo for acute postoperative pain management.

These findings indicate that treatment with fentanyl sublingual spray results in effective relief of BTCP, with a rapid onset of action, and is well tolerated.

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