Pain practice : the official journal of World Institute of Pain
-
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.
-
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.