Pain
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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 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.
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Randomized Controlled Trial Comparative Study Clinical Trial
Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction.
Patient self-reports are the primary method for capturing the experience of pain, and diaries are often used to collect patient self-reports. This study was designed to determine if momentary monitoring of pain with an electronic diary affected pain levels over time, if it affected weekly recall of pain, and if daily sampling density affected compliance rates and patients' reactions to the study. ⋯ Compliance with the electronic diary protocol was 94% or better, and was not related to sampling density. Patients reported little difficulty with the diary procedures and were not unduly burdened by the protocol.
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Randomized Controlled Trial Clinical Trial
Gut pain and hyperalgesia induced by capsaicin: a human experimental model.
Human experimental visceral pain models using chemical stimulation are needed for the study of visceral hyperexcitability. Our aim was to stimulate the human gut with chemical activators (capsaicin, glycerol) and measure quantitatively the induced hyperexcitability to painful mechanical gut distension. Ten otherwise healthy subjects with an ileostoma participated. ⋯ No significant manifestations were found after application of glycerol and saline. Application of capsaicin to the human ileum induces pain and mechanical hyperalgesia. Specific activation of nociceptors in the gut mucosa provides new possibilities to study clinical relevant visceral pain mechanisms.
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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).