Journal of pain and symptom management
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J Pain Symptom Manage · Aug 2003
Randomized Controlled Trial Comparative Study Clinical TrialA pharmacokinetic study to compare two simultaneous 400 microg doses with a single 800 microg dose of oral transmucosal fentanyl citrate.
It is unknown whether two smaller doses of oral transmucosal fentanyl citrate (OTFC) administered simultaneously are pharmacokinetically equivalent to an identical dose administered as a single unit. This issue has important practical implications when patients are attempting to identify the appropriate dosage of OTFC to control their pain. This open-label, randomized, crossover design study compared the pharmacokinetics of two simultaneously consumed 400 microg OTFC doses with one 800 microg OTFC dose in 12 healthy volunteers. ⋯ Area under the curve (AUC) was 8.2 ng/ml.hr (SE=1.1) and 7.2 ng/ml.hr (SE=1.0). There were no significant differences between the treatment groups in either the time to peak concentration (Tmax) or the mean residence time (MRT). The results demonstrate the bioequivalence of two 400 microg with one 800 microg OTFC units.
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J Pain Symptom Manage · Jun 2003
Randomized Controlled Trial Clinical TrialPilot study to determine the effectiveness of diamorphine gel to control pressure ulcer pain.
Pressure ulcer pain, a common problem among palliative care patients, does not respond well to oral analgesics. There have been case reports in the medical literature describing the successful use of topical opioids for painful skin conditions. So far, these topical opioids have not been compared to placebo. ⋯ Pain scores improved significantly after diamorphine gel application compared with placebo (P<0.05). Diamorphine gel appears to be an effective treatment for pain caused by stage II or III pressure ulcers. It is probably as safe as placebo in regards to side effects, but a larger study would be required to confirm these results.
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J Pain Symptom Manage · Feb 2003
Randomized Controlled Trial Multicenter Study Clinical TrialThe COX-2 specific inhibitor, valdecoxib, is an effective, opioid-sparing analgesic in patients undergoing total knee arthroplasty.
This multicenter, randomized, double-blind, placebo-controlled study evaluated the analgesic efficacy and opioid-sparing effects of valdecoxib, a potent COX-2 specific inhibitor, in patients undergoing knee replacement. Patients received morphine by patient-controlled analgesia (PCA), and valdecoxib 40 mg or 80 mg daily, or placebo, for up to two days. Efficacy was assessed by the cumulative amount of morphine administered over 48 hours, pain intensity and patient's evaluation of medication. ⋯ Patients receiving valdecoxib 40 mg and 80 mg daily experienced significantly lower maximum pain intensity on Day 2 (P < 0.05), and rated their study medication significantly higher than patients receiving morphine alone. Valdecoxib plus morphine was well tolerated. Thus, valdecoxib in combination with morphine provides multi-modal analgesia that reduces pain and opioid use and increases patient satisfaction following knee replacement surgery.
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J Pain Symptom Manage · Feb 2003
Randomized Controlled Trial Clinical TrialFactor analysis of laboratory and clinical measurements of dyspnea in patients with chronic obstructive pulmonary disease.
The primary purpose of this study was to determine if there are three distinct factors representing ratings of dyspnea during laboratory exercise, clinical ratings of dyspnea, and pulmonary function in patients with moderate to severe chronic obstructive pulmonary disease (COPD) (n = 92) using factor analysis. Subjects (mean age 66 +/- 7 yrs; FEV1% predicted 44.7 +/- 14.0) were randomly assigned to one of three treatment groups to test the effects of three education and exercise training programs. Outcomes were evaluated at baseline and at 2 months after the intervention. ⋯ Measures of airway resistance (FEV1% predicted, FEV1/FVC) and hyperinflation (RV/TLC) loaded on a third factor, "Pulmonary Function." An additional post hoc factor analysis with post-intervention data provided similar results. The Global SOB question and ITT SOB isostage variables were relatively more sensitive to change compared to the other outcome variables. We conclude that pulmonary function, clinical ratings of dyspnea, and laboratory ratings of dyspnea are three separate and independent factors and should be included in the routine clinical evaluation of patients with COPD.
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J Pain Symptom Manage · Sep 2002
Comment Letter Randomized Controlled Trial Clinical TrialRe: nebulized furosemide for dyspnea in terminal cancer patients.