Pain
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Tramadol in post-herpetic neuralgia: a randomized, double-blind, placebo-controlled trial.
The efficacy and safety of sustained-release tramadol compared to placebo in the treatment of post-herpetic neuralgia were evaluated in a multicenter, randomized, double-blind, parallel-group study in 127 outpatients. Treatment was administrated for 6 weeks. The dose of tramadol could be increased from 100 mg/day to 400 mg/day (300 mg/day in patients more than 75 years old). ⋯ Tramadol was administered at an average dosage of 275.5 (89.7) mg/day after a 1-week dose-adaptation period. Tramadol was well tolerated. No notable difference appeared between groups either in the percentage of patients with treatment-associated adverse events (TAAE) (29.7% in the tramadol group and 31.8% in the placebo group) or in the total number of TAAE (31 in the tramadol group and 28 in the placebo group).
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Double-blind evaluation of short-term analgesic efficacy of orally administered dexketoprofen trometamol and ketorolac in bone cancer pain.
The analgesic efficacy and safety of dexketoprofen trometamol (the active enantiomer of the racemic compound ketoprofen) (25mg q.i.d.) vs. ketorolac (10mg q.i.d.) was assessed in 115 patients with bone cancer pain included in a multicenter, randomized, double-blind, parallel group study. A level of >/=40 mm on the 100 mm visual analog scale (VAS) and >/=10 in the pain rating index were required for inclusion. At the end of treatment on day 7 (+1 day), mean values of VAS were 32+/-24 mm for dexketoprofen and 40+/-30 mm for ketorolac (P=0.12) but the pain rating index was significantly lower in patients given dexketoprofen (8.5+/-2.3 vs. 9.7+/-2.9, P=0.04). ⋯ Treatment-related adverse events occurred in 16% of patients given dexketoprofen and in 24% given ketorolac. Serious adverse events occurred in 3.5% of patients from both groups but only one case of gastrointestinal hemorrhage was considered related to ketorolac. We conclude that dexketoprofen trometamol 25 mg q.i.d. oral route is a good analgesic therapy in the treatment of bone cancer pain, comparable to ketorolac 10 mg q.i.d., with a good tolerability profile.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
The treatment of complex regional pain syndrome type I with free radical scavengers: a randomized controlled study.
To compare the effects of two free radical scavengers, dimethylsulfoxide 50% (DMSO) and N-acetylcysteine (NAC), for treatment of complex regional pain syndrome I (CRPS I), a randomized, double-dummy controlled, double-blind trial was conducted. Two outpatient clinics of two university hospitals in The Netherlands participated in the study and 146 patients, were included over a period of 24 months. Patients were randomized into two treatment groups, one was instructed to apply DMSO 50% five times daily to the affected extremity, the second was treated with NAC 600mg effervescent tablets three times daily, both combined with placebo. ⋯ Results tended to be negatively influenced if the duration of the complaint was longer. Treatment with DMSO and NAC are generally equally effective in treatment of CRPS I. Strong indications exist for differences in effects for subgroups of patients with warm or cold CRPS I: for warm CRPS I, DMSO-treatment appears more favorable, while for cold CRPS I, NAC-treatment appears to be more effective.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Gabapentin in neuropathic pain syndromes: a randomised, double-blind, placebo-controlled trial.
A double-blind, randomised, placebo-controlled 8-week study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain, using doses up to 2400 mg/day. The study used a novel design that was symptom- rather than syndrome-based; an approach that aimed to reflect the realities of clinical practice. Participants had a wide range of neuropathic pain syndromes, with at least two of the following symptoms: allodynia, burning pain, shooting pain, or hyperalgesia. ⋯ Gabapentin was well tolerated and the majority of patients completed the study (79 versus 73% for placebo). The most common adverse events were mild to moderate dizziness and somnolence, most of which were transient and occurred during the titration phase. This study shows that gabapentin reduces pain and improves some quality-of-life measures in patients with a wide range of neuropathic pain syndromes.
-
Randomized Controlled Trial Multicenter Study Clinical Trial
Intra-articular morphine as analgesic in temporomandibular joint arthralgia/osteoarthritis.
The aim of this study was to determine the analgesic efficacy of a single dose intra-articular injection (i.a.) of morphine in 53 patients with unilateral arthralgia/osteoarthritis of the temporomandibular joint (TMJ). This randomized, double-blind, parallel group, multicenter study included a screening visit, a treatment visit, and a follow-up visit 1 week after treatment. Recordings of visual analog scales (VAS) pain intensity scores at maximum mouth opening (main efficacy variable) and at jaw rest were made directly before a 1-ml i.a. injection into one TMJ of either 1.0mg morphine-HCl, 0.1mg morphine-HCl, or saline (placebo). ⋯ In conclusion, one i.a. injection of 0.1mg morphine significantly increased the pain pressure threshold and mouth opening ability, but evidence for the analgesic property of the locally applied opioid was inconclusive. No dose-effect relation and no significant short-term analgesic property were seen. Although statistically significant, the magnitude of the reduced VAS pain intensity score was not clinically relevant at the 1-week follow-up.