Pain
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens.
Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). ⋯ The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation.
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Randomized Controlled Trial Multicenter Study Clinical Trial
MorphiDex (morphine sulfate/dextromethorphan hydrobromide combination) in the treatment of chronic pain: three multicenter, randomized, double-blind, controlled clinical trials fail to demonstrate enhanced opioid analgesia or reduction in tolerance.
While many pre-clinical and clinical studies have suggested that the addition of N-methyl-D-aspartate (NMDA) receptor antagonists, such as dextromethorphan (DM), to opioid analgesics, such as morphine (MS), may enhance the analgesic effects and prevent the tolerance that may result from chronic opioid administration, others have not. The potential for reduced doses, enhanced opioid analgesia, and decreased analgesic tolerance associated with the MS/DM combination were evaluated in a series of three large, randomized, double-blind, parallel group, phase 3, multicenter trials each of 3 months duration in patients with chronic, non-malignant, non-neuropathic pain. To evaluate these unique endpoints, novel study designs were employed. ⋯ In Studies B and C, patients self-titrated doses of MS or MS/DM, based on stable doses of MS or other opioids attained during Run-in periods, to maintain pain relief; percentage changes from baseline in MS (or MS-equivalent) doses were compared. No statistically significant differences between treatment groups in any primary or secondary efficacy variables were demonstrated in any trial. These results suggest that adding the NMDA antagonist, dextromethorphan, to opioids does not add any clinical benefit.
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Randomized Controlled Trial Clinical Trial
Assessment of the effectiveness of peripheral administration of morphine with local articaine anaesthesia for surgery in inflamed oral and maxillofacial tissues.
The controversy surrounding clinical trials of peripherally applied morphine with local anaesthetic and the attendant ambiguous results led to a study of our own clinical material. The aim of the study was to assess the effectiveness of peripheral administration of morphine with local articaine anaesthesia in inflamed oral and maxillofacial tissues. Sixty patients who qualified for the randomized, double-blinded study were randomly divided into two groups. ⋯ Moreover, during the next 12 h, there were significant differences observed in the level of pain between both groups. There was also considerable difference between both groups in the time of first analgesic intake and the total amount of analgesic. Our results show that modified local anaesthesia may be of benefit for the relief of operative and post-operative pain and may also help reduce analgesic intake after oral surgery.
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The relationship between temporo-spatial stimulus parameters and evoked pain intensity as well as duration was examined in patients with peripheral neuropathy and brush-evoked allodynia, i.e. dynamic mechanical allodynia. Brush-evoked allodynia was induced in the innervation territory of the lesioned nervous structure in 18 patients by lightly stroking different distances of the skin (20, 40, 60 mm) two or four times with brushes of different widths (4, 8, 16 mm). Pain intensity and duration of brush-evoked allodynia was recorded using a computerized visual analogue scale. ⋯ Significantly increased duration of aftersensation was demonstrated only following increased brushing length (P<0.008). The most commonly used sensory-discriminative pain descriptors were pricking, burning and sore and for the affective descriptors, annoying and troublesome. This is the first study demonstrating a relationship between evoked pain and some temporo-spatial stimulus parameters during brush-evoked allodynia.