Journal of pain and symptom management
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J Pain Symptom Manage · Jan 1998
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of senna versus lactulose in terminal cancer patients treated with opioids.
The best laxative for terminal cancer patients treated with opioids still remains to be determined. This comparative study was conducted with the objective of determining treatment and cost efficiency for senna and lactulose in terminal cancer patients treated with opioids. The methodology used a randomized, open, parallel group design. ⋯ No difference was found between the laxatives in defecation-free intervals or in days with defecation. The final scores for general health status were similar in both groups. Given that the two treatments have similar efficacy and adverse effects, a recommendation is made for the use of senna because its cost is lower than lactulose.
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J Pain Symptom Manage · Aug 1997
Randomized Controlled Trial Comparative Study Clinical TrialComparison of a once-a-day sustained-release morphine formulation with standard oral morphine treatment for cancer pain.
Kadian/Kapanol (K) is a capsule formulation of morphine designed for 12- or 24-hourly dosing. This double-blind study compared the efficacy and safety of K every 24 hr to K every 12 hr and MS Contin tablets (MSC) every 12 hr. One hundred fifty-two patients with cancer pain were titrated to adequate analgesia with immediate-release morphine (IRM) solution. ⋯ Patient global assessment significantly favored K every 24 hr over MSC every 12 hr (P = 0.018). There were no statistically significant differences among the treatments for any morphine-related side effects when adjusted for baseline. K had efficacy and safety profiles similar to MSC every 12 hr but had the advantage of 12- or 24-hourly administration.
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J Pain Symptom Manage · Jun 1997
Randomized Controlled Trial Clinical TrialThe effects of pre-emptive treatment of postherpetic neuralgia with amitriptyline: a randomized, double-blind, placebo-controlled trial.
Seventy-two patients older than 60 years of age who received a diagnosis of herpes zoster (HZ) were entered into a randomized, double-blind, placebo-controlled trial of daily amitriptyline 25 mg. Treatment with either amitriptyline or placebo continued for 90 days after diagnosis. Pain prevalence at 6 months was the primary outcome. Results showed that early treatment with low-dose amitriptyline reduced pain prevalence by more than one-half (p < 0.05; odds ratio, 2.9:1) This finding makes a strong case for the pre-emptive administration of amitriptyline, in combination with an antiviral drug, to elderly patients with acute herpes zoster.
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J Pain Symptom Manage · May 1997
Randomized Controlled Trial Comparative Study Clinical TrialTransdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life. The TTS-Fentanyl Comparative Trial Group.
Cancer patients requiring strong opioid analgesia (n = 202; mean age, 61.5 years; range, 18-89 years; 55% men) were recruited from 38 United Kingdom palliative care centers into a randomized, open, two-period, crossover study comparing transdermal fentanyl with sustained-release oral morphine. Patients received one treatment for 15 days followed immediately by the other for 15 days. Daily diaries were completed. ⋯ Of those patients who were able to express a preference (n = 136), significantly more preferred the fentanyl patches (p = 0.037). We conclude that, in this study, transdermal fentanyl provided pain relief that was acceptable to cancer patients and was associated with less constipation and sedation than morphine. These reduced side effects may contribute to patients preference for the patches.
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J Pain Symptom Manage · Feb 1997
Randomized Controlled Trial Clinical TrialA pharmacokinetic/pharmacodynamic study of controlled-release oxycodone.
A single-dose, analytically blinded, randomized, crossover study was conducted in 22 healthy male volunteers to compare the bioavailability of one 20 mg with two 10 mg controlled-release (CR) oxycodone tablets. In addition, pharmacodynamic effects were assessed using both objective and subjective measures for up to 48 hr after dosing. The two treatments were bioequivalent, with comparable rates (Cmax of one 20 mg tablet was 109% of two 10 mg tablets; 90% confidence limits: 98.4%-120%) and extents (AUC0-infinity: 107%; 100%-114%) of absorption. ⋯ Correlations between plasma oxycodone concentrations and most pharmacodynamic measures were significant. The strongest correlations were observed for pupil size (r = -0.53) and subjects' assessment of drug effect (r = 0.53), with changes in plasma concentration accounting for more than 25% of the observed changes in these variables. This study demonstrated bioequivalence of two 10 mg and one 20 mg CR oxycodone tablet, with significant correlation between plasma oxycodone concentrations and pharmacodynamic effects in normal volunteers.