Articles: opioid.
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Randomized Controlled Trial Multicenter Study
Efficacy and Tolerability of Buccal Buprenorphine in Opioid-Experienced Patients With Moderate to Severe Chronic Low Back Pain: Results of a Phase 3, Enriched Enrollment, Randomized Withdrawal Study.
A buccal film of buprenorphine (BBUP) was evaluated for safety and efficacy in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-experienced patients (30 to ≤160 mg/d morphine sulfate equivalent) with moderate to severe chronic low back pain taking around-the-clock opioid analgesics. Patients' opioid doses were tapered to ≤30 mg morphine sulfate equivalent before open-label titration with BBUP (range, 150-900 μg every 12 hours). Patients who responded (received adequate analgesia that was generally well tolerated for 14 days) were randomized to receive buprenorphine (n = 254) or placebo (n = 257) buccal film. ⋯ A significantly larger percentage of patients receiving BBUP than placebo had pain reductions ≥30% and ≥50% (P < 0.001 for both). In the double-blind portion of the study, the only adverse event reported more frequently with BBUP than placebo and in ≥5% of patients was vomiting (5.5% vs 2.3%). These findings demonstrate the efficacy and tolerability of BBUP in opioid-experienced patients taking around-the-clock opioid treatment for chronic low back pain.
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Randomized Controlled Trial Multicenter Study
Efficacy and Safety of Radium-223 Dichloride in Symptomatic Castration-resistant Prostate Cancer Patients With or Without Baseline Opioid Use From the Phase 3 ALSYMPCA Trial.
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Multicenter Study
Impact of an Electronic Pain and Opioid Risk Assessment Program: Are There Improvements in Patient Encounters and Clinic Notes?
A comprehensive electronic self-report assessment, called PainCAS(®) (Clinical Assessment System), was developed and implemented in three clinics. PainCAS captures demographic information, pain assessment, quality-of-life variables, and contains validated, electronic versions of screeners for risk of aberrant opioid-related behaviors (the SOAPP and COMM). This investigation sought to determine the impact of PainCAS on documentation of pain and opioid risk evaluations. Exploratory hypotheses examined changes in the content of the patient-provider interaction and any impact on outcome. ⋯ Results indicate that use of the PainCAS electronic pain assessment improves documentation of chart elements in clinic notes and is associated with increased discussion of key, pain-relevant topics during the clinical visit.
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Randomized Controlled Trial Multicenter Study
SoluMatrix® Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain.
To evaluate opioid rescue medication usage and the opioid-sparing effect of low-dose SoluMatrix(®) diclofenac developed using SoluMatrix Fine Particle Technology™ in a phase 3 study in patients experiencing pain following bunionectomy surgery. ⋯ The opioid-sparing effect following low-dose SoluMatrix diclofenac (35 mg or 18 mg three times daily) administration was evaluated in patients experiencing pain following bunionectomy. Significantly fewer patients receiving SoluMatrix diclofenac or celecoxib (400 mg loading, 200 mg twice daily) required rescue medication during 0-24 h and >24-48 h following bunionectomy compared with placebo. No serious adverse events were reported among patients who received SoluMatrix diclofenac. SoluMatrix diclofenac may reduce opioid usage in the postoperative setting in patients with acute pain.
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Multicenter Study
Patients' Perspectives on Tapering of Chronic Opioid Therapy: A Qualitative Study.
OBJECTIVE : There is inadequate evidence of long-term benefit and growing evidence of the risks of chronic opioid therapy (COT). Opioid dose reduction, or opioid tapering, may reduce these risks but may also worsen pain and quality of life. Our objective was to explore patients' perspectives on opioid tapering. ⋯ These patients endorsed improved quality of life following tapering. CONCLUSIONS : Efforts to support opioid tapering should elicit patients' perceived barriers and seek to build on relationships with family, peers, and providers to facilitate tapering. Future work should identify patient-centered, feasible strategies to support tapering of COT.