Journal of pain and symptom management
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J Pain Symptom Manage · Jul 2004
ReviewA comprehensive review of clinical trials on the efficacy and safety of drugs for the treatment of low back pain.
A systematic review involving 50 randomized controlled trials (4,863 patients) published since 1980 was undertaken with the objective of assessing efficacy and safety of low back pain (LBP) medications. The methodological quality of each trial was evaluated based on a standardized system. ⋯ Available evidence supported the effectiveness of non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in acute and chronic LBP, of muscle relaxants in acute LBP, and of antidepressants in chronic LBP; safety results were heterogeneous. More rigorously designed trials should be implemented to establish comparative efficacy and safety of drugs used to treat chronic and acute LBP.
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J Pain Symptom Manage · Jul 2004
Randomized Controlled Trial Clinical TrialEfficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee.
The efficacy and safety of a once-daily extended-release formulation of tramadol hydrochloride (tramadol ER) was evaluated in patients with moderate to severe chronic pain of osteoarthritis (OA). This was a randomized, double-blind, placebo-controlled, parallel-group, 12-week study. Eligible patients with radiographically confirmed OA of the knee meeting the American College of Rheumatology diagnostic criteria, defined by knee pain and presence of osteophytes, plus at least age >50 years, morning stiffness <30 minutes in duration, and/or crepitus, entered a 2-7 day washout period during which all analgesics were discontinued. ⋯ Similarly, outcomes on the WOMAC Pain, Stiffness and Physical Function subscales, the WOMAC Composite Scale, dropouts due to insufficient therapeutic effect, Patient and Physician Global Assessment of Therapy, and Sleep were all significantly better with tramadol ER than placebo (P < 0.001 to < 0.05). Treatment with tramadol ER results in statistically significant and clinically important and sustained improvements in pain, stiffness, physical function, global status, and sleep in patients with chronic pain. A once-a-day formulation of tramadol has the potential to provide patients increased control over the management of their pain, fewer interruptions in sleep and improved compliance.
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J Pain Symptom Manage · Jul 2004
Dose-response relationship between opioid use and adverse effects after ambulatory surgery.
This health outcomes analysis based on data from a randomized, double-blind, placebo-controlled trial determined dose-response relationship between opioid use and related symptoms. All patients received intravenous fentanyl on demand for pain predischarge, and oral acetaminophen 500 mg/hydrocodone 5 mg every 4-6 hours as needed postdischarge for up to 7 days postsurgery. Patients completed an opioid-related Symptom Distress Scale (SDS) questionnaire every 24 hours postdischarge for 7 days, which assessed 12 opioid-related symptoms by 3 ordinal measures: frequency, severity, and bothersomeness. ⋯ Regression analyses suggested that once the MED reached a threshold, approximately every 4 mg increase in MED was related to 1 additional patient-CME-day (P<0.01). A dose-response relationship empirically exists between MED and directly assessed opioid-related CMEs after ambulatory laparoscopic cholecystectomy. Once daily MED reaches a threshold, every 3-4 mg increase will be associated with 1 additional clinically meaningful opioid-related symptom, or 1 additional patient-day with an opioid-related CME.
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Undertreatment of pain resulting in physiological, psychosocial, and economic consequences continues despite targeted improvement approaches. Starck et al. propose a systems framework for study of pain management errors. This secondary analysis examined pain outcomes of hospitalized inpatients to determine factors predicting adequate pain management. ⋯ Logistic regression predicted adequate pain management based on analgesic rating, ethnicity, age, and educational level with 0.89 accuracy. The study findings support conceptualizing mismanagement of pain as a medical error. An intervention model describes the use of a systems approach to identify high risk patients and ensure effective pain management practices for all.