Pain
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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).
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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.
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Randomized Controlled Trial Clinical Trial
Injection of nerve growth factor into human masseter muscle evokes long-lasting mechanical allodynia and hyperalgesia.
Nerve growth factor (NGF) is a neurotrophic protein with a pivotal role in development and maintenance of the nervous system on one side and inflammatory and neuropathic pain states on the other. NGF causes clear signs of behavioral hyperalgesia in animal models and following intradermal and systemic administration in humans. The present double-blinded, placebo-controlled study was designed to test quantitatively the effect and duration (1h, 1, 7, 14, 21 and 28 days) of NGF (5 microg in 0.2 ml) injected into the masseter muscle. ⋯ Systemic adverse effects were noted in one subject who reported fever and slight discomfort about 8h after the NGF injection. In conclusion, this is the first study to show that injection of NGF into the human masseter muscle causes local signs of mechanical allodynia and hyperalgesia that persist for at least 7 days as well as pain during strenuous jaw movement. The present pain model is safe and may be used to gain further insight into the neurobiological mechanisms of muscle pain and sensitization.
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Randomized Controlled Trial Comparative Study Clinical Trial
Intra-articular (IA) catheter administration of postoperative analgesics. A new trial design allows evaluation of baseline pain, demonstrates large variation in need of analgesics, and finds no analgesic effect of IA ketamine compared with IA saline.
All previous studies of intra-articular (IA) analgesic drugs for postarthroscopy pain have administered test-drugs at the end of the arthroscopic procedure, before any baseline pain could be assessed. Assay sensitivity has often not been documented or has been assumed to be present if a placebo control group had significant pain during the observation period. We present an improved study design employing an IA catheter for test-drug administration only in patients with moderate-to-severe baseline pain within 2h postoperatively. ⋯ The new method for IA analgesic trials solves the problem with undesirable inclusion of patients with no or mild pain. We observed rapid onset and significant pain relief after IA injection of 10 ml saline with or without ketamine 10mg, but no difference between these two test medications. Intra-muscular ketamine 10mg showed significantly better early pain relief, global evaluation, and longer time to rescue analgesic, compared with IA ketamine 10mg.
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Randomized Controlled Trial Comparative Study Clinical Trial
EMLA cream and oral glucose for immunization pain in 3-month-old infants.
The objective of this study is to determine whether use of lidocaine-prilocaine 5% cream (EMLA) and oral glucose decreases pain associated with diphteria-pertussis-tetanus (DPT) immunization in 3-month-old infants. ⋯ randomized, double-blind, controlled trial in outpatient paediatric practice in northern Sweden. EMLA or placebo was applied to the infant's lateral region of the right thigh and covered with an occlusive dressing 1h before the immunization. In addition, 1 ml of glucose (300 mg/ml) or placebo (water) was instilled on the baby's tongue within 2 min before the DPT-injection. Forty-five infants received EMLA and glucose and 45 infants placebo cream and water. ECG was recorded and stored in a computer and the procedure was videotaped. The parents and the nurse assessed the infants' pain on a visual analogue scale (VAS) after the immunization. Heart rate and heart rate variability pre- and post-injection were calculated. From the videotapes, the modified behavioural pain scale (MBPS) was used to assess pain scores during baseline and after immunization. The latency of the first cry and total crying time were measured. The parents and the nurse scored the infants' pain on the VAS significantly lower in the treatment group than in the placebo group. The infants' responses to the immunization measured as the difference in MBPS scores pre- and post-injection were significantly lower in the EMLA-glucose group compared with the placebo group. More infants cried after the immunization in the placebo group compared with the EMLA-glucose group and the latency of the first cry after the injection was shorter in the placebo group. A biphasic transient heart rate response with a marked deceleration followed by a subsequent acceleration was seen more frequently in the placebo group compared to the EMLA-glucose group. EMLA and glucose alleviate immunization pain in 3-month-old infants.