Journal of opioid management
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Review Multicenter Study
The safety and tolerability of the fentanyl HCl iontophoretic transdermal system: an alternative to currently available analgesic modalities.
The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is an analgesic modality approved for the management of acute postoperative pain. The fentanyl ITS uses a generally imperceptible electrical field to drive fentanyl across the skin and into the bloodstream. Unlike intravenous patient-controlled analgesia (PCA), fentanyl ITS is needle free and preprogrammed, eliminating the risks of needlestick injury and programming errors. Its efficacy, safety, and tolerability were assessed in several clinical trials, and this article presents the integrated safety and tolerability of fentanyl ITS using data pooled from these studies. ⋯ The fentanyl ITS addresses certain safety issues of existing modalities while providing comparable pain relief making it an attractive option for postoperative pain management.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid OAD).
This placebo-controlled study examined the analgesic efficacy, safety, and clinical benefit of Tramadol Contramid OAD, a once-daily formulation with both immediate- and extended-release components. Five hundred and fifty-two patients with moderate to severe pain due to osteoarthritis (OA) of the knee were randomized into this multicenter, double-blind, parallel arm study. After randomization to Tramadol Contramid OAD 100, 200, or 300 mg, or to placebo, patients' dose was titrated to the fixed randomized dose and maintained for 12 weeks. ⋯ The responder analysis demonstrated a statistically significant difference in the percentage of patients who achieved a 30 percent improvement in their baseline WOMAC pain score for both Tramadol Contramid OAD 200 mg (65 percent; p = 0.0095) and 300 mg (65 percent; p = 0.0104) compared with placebo (50 percent). The type and incidence of adverse events were typical of tramadol (nausea, dizziness/vertigo, vomiting, somnolence, and constipation) and the intensity was mild to moderate in 87percent of patients who experienced them regardless of dose. This study shows the efficacy and safety of Tramadol Contramid OAD 200 mg and 300 mg in patients with moderate or severe pain of the knee due to OA.
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The Pain Medication Questionnaire (PMQ), initially developed by Adams et al. (J Pain Symptom Manage. 2004; 27: 440-459), is a 26-item self-report assessment to screen for opioid-medication misuse. The PMQ has demonstrated good reliability and validity, and was predictive of early termination from treatment and identified patients who demonstrated maximal benefit from interdisciplinary treatment (Holmes et al. Pain Pract. 2006; 6: 74-88). ⋯ Thus, although a PMQ total score > or =25 is indicative of problematic use, a score > or =30 suggests that a patient should be closely monitored when prescribed an opioid medication. Overall, this study again demonstrated that a patient's self-report is significantly correlated with problematic behaviors observed by physicians. Therefore, when utilized in a busy clinic setting, the PMQ will aide in the identification of specific problematic behaviors and beliefs at the outset of treatment that may hinder successful treatment of a patient's pain condition.