Key result
Fentanyl ITS was statistically equivalent to morphine IV PCA for acute pain control after total-hip replacement, with 83.0% vs 82.2% achieving excellent or good success ratings.
Why the study?
Does fentanyl ITS provide equivalent pain control compared to morphine IV PCA in patients after unilateral total-hip replacement?
RCT (n=799)
Open-label
Yes
Does fentanyl ITS provide equivalent pain control compared to morphine IV PCA in patients after unilateral total-hip replacement?
Effect estimate: Difference 0.9% (95% CI -4.4% to 6.1%)
Absolute Event Rate: 83% vs 82.2%
Fentanyl ITS provides comparable acute postoperative pain control to standard morphine IV PCA after total hip replacement.
Supports fentanyl ITS as a non-invasive alternative to morphine IV PCA after THR; confirms equivalence in Level 2 evidence for acute pain.
Background and Objectives: The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR). Methods: In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 μg fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR. The primary efficacy measure was success ratings (“excellent” or “good”) on the patient global assessment (PGA) of the method of pain control in the first 24 hours. Pain intensity and adverse events were also assessed. Results: The PGA success ratings (83.0% v 82.2%; difference = 0.9%; 95% CI: −4.4% to 6.1%) and the mean last pain-intensity scores (3.0 v 3.0; difference = 0.0; 95% CI: −0.33 to 0.33) in the first 24 hours were statistically equivalent between fentanyl ITS and morphine IV PCA groups, respectively. The incidence of adverse events was similar between the groups. Conclusions: Results of this study demonstrate fentanyl ITS and a standard regimen of morphine IV PCA were comparable methods of pain control for management of acute postoperative pain after THR, on the basis of the PGA success ratings and pain intensity in the first 24 hours of treatment.
No takes yet. Share an insight, caveat, or question.
Charles D. Deakin (2005) conducted an RCT in Acute postoperative pain after unilateral total-hip replacement (n=799). Fentanyl HCl iontophoretic transdermal system (ITS) vs. Morphine intravenous patient-controlled analgesia (1-mg bolus, 5-minute lockout, up to 10 mg/h) was evaluated on Success ratings ('excellent' or 'good') on the patient global assessment (PGA) of the method of pain control in the first 24 hours (Difference 0.9%, 95% CI -4.4% to 6.1%). Fentanyl ITS was statistically equivalent to morphine IV PCA for acute pain control after total-hip replacement, with 83.0% vs 82.2% achieving excellent or good success ratings.
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: