Pain practice : the official journal of World Institute of Pain
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Randomized Controlled Trial
Consistent and clinically relevant effects with fentanyl buccal tablet in the treatment of patients receiving maintenance opioid therapy and experiencing cancer-related breakthrough pain.
Fentanyl buccal tablet (FBT) has shown efficacy and tolerability in patients with cancer-related persistent pain treated with maintenance opioids. We conducted a combined analysis of two similarly designed, randomized, placebo-controlled studies to further evaluate the consistency and clinical relevance of analgesia outcomes. Of the 252 patients enrolled, 150 fulfilled the criteria for efficacy analysis and experienced 1,417 breakthrough pain episodes. ⋯ Application-site (buccal) abnormalities were infrequent and led to withdrawal of three patients. There were no serious adverse events or deaths attributable to FBT. This analysis suggests that FBT provides an analgesic effect that is consistent across multiple clinically relevant efficacy measures.
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Randomized Controlled Trial Comparative Study
Effect of intravenous lidocaine on manifestations of fibromyalgia.
The objective of our study was to evaluate the effect of intravenous lidocaine on the manifestations of fibromyalgia. ⋯ The addition of 240 mg intravenous lidocaine (once a week) to 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia compared with amitriptyline alone.
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Review Randomized Controlled Trial Historical Article
Preliminary observations of a novel topical oil with analgesic properties for treatment of acute and chronic pain syndromes.
Essential oxygen oil (OxyRub from CreoMed Inc., Naples, FL, U.S.A.) is a novel topical analgesic currently commercially available in Europe and now available in the U.S.A. It represents an important alternative to other treatments (nonsteroidal anti-inflammatory drugs, acetaminophen, menthol, camphor) for managing mild to moderate acute and chronic pain. Several clinical trials of this oil will be reviewed. ⋯ Based on studies completed, essential oxygen oil has shown itself to be safe, has demonstrated positive analgesic effects for the treatment of acute and chronic pain, and has improved oxygen content in the skin as well as other dermatological parameters.
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Randomized Controlled Trial Clinical Trial
Effect of rectal diclofenac in reducing postoperative pain and rescue analgesia requirement after cardiac surgery.
Adequate analgesic medication is mandatory after coronary artery bypass grafting (CABG) surgery. The aim of this study was to assess the analgesic efficacy, side effects, and need for rescue analgesia after CABG surgery comparing diclofenac and placebo rectal suppository. ⋯ Rectal diclofenac suppository with tramadol provides adequate pain relief after cardiac surgery, and also reduces tramadol consumption and side effects commonly associated with tramadol.
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Randomized Controlled Trial Clinical Trial
Pain responder analysis: use of area under the curve to enhance interpretation of clinical trial results.
Interpretation of results on patient-reported pain outcomes from clinical trials should be meaningful to patients and healthcare providers. This study applied an area-under-the-curve (AUC) analysis to responder profiles in a clinical trial of pregabalin for the treatment of fibromyalgia (FM). Data were from a 14-week, randomized, placebo-controlled trial of pregabalin (300, 450, or 600 mg/day) for the treatment of FM in patients meeting American College of Rheumatology criteria for FM and with a baseline pain score of at least 40 mm on the 100-mm pain visual analogue scale. ⋯ The AUCs (2,100 for placebo, and 2,944, 3,170, and 3,349 for pregabalin 300, 450, and 600 mg, respectively) can be considered as if every responder improved by 21, 29, 31, and 33.5% in the responder's respective treatment group. Pain improvement was significantly better with pregabalin (P < 0.05), with pregabalin responders improving by 8.4% (300 mg/day), 10.7% (450 mg/day), and 12.5% (600 mg/day) more than placebo responders. This novel approach demonstrates that responder profiles can provide an enhanced interpretation of pain outcomes for patient care and symptom management.