Articles: analgesics.
-
Br J Clin Pharmacol · Aug 2015
Randomized Controlled Trial Multicenter StudyCYP2B6*6 allele and age substantially reduce steady-state ketamine clearance in chronic pain patients: impact on adverse effects.
Ketamine analgesia is limited by low intrinsic efficacy compounded by large interindividual variability in drug responses, possibly due to the heterogeneity in drug concentration. The CYP2B6*6 allele is associated with substantially reduced ketamine metabolism in vitro and, therefore, may affect ketamine clearance. Our aims were to examine the impact of the CYP2B6*6 allele on ketamine plasma clearance and on adverse effects in chronic pain patients. ⋯ The CYP2B6*6 allele is associated with a substantial decrease in steady-state ketamine plasma clearance in chronic pain patients. The decreased clearance and resultant higher plasma concentrations may be associated with a higher incidence of ketamine adverse effects.
-
Orthopaedic surgery · Aug 2015
Randomized Controlled Trial Multicenter Study Comparative StudyIntra-articular Adjuvant Analgesics following Knee Arthroscopy: Comparison between Single and Double Dose Dexmedetomidine and Ropivacaine A Multicenter Prospective Double-blind Trial.
Knee arthroscopy is a commonly performed orthopedic procedure. Post-operatively, adequate pain relief reduces the surgical stress response and patient's morbidity and facilitates rehabilitation. The analgesic effect of dexmedetomidine (2 μg/kg body weight) as an adjunct to ropivacaine in knee arthroscopic knee procedures was studied to determine whether this would achieve longer post-operative analgesia and whether the study dosage of dexmedetomidine was safe and free of adverse effects. ⋯ Intra-articular dexmedetomidine (2 μg/kg) has superior analgesic efficacy, delayed the first postoperative requirement for analgesia and decreasing the need for postoperative analgesics with no major adverse effects.
-
Multicenter Study Observational Study
[Sedation and analgesia practices among Spanish neonatal intensive care units].
Pain management and sedation is a priority in neonatal intensive care units. A study was designed with the aim of determining current clinical practice as regards sedation and analgesia in neonatal intensive care units in Spain, as well as to identify factors associated with the use of sedative and analgesic drugs. ⋯ Almost half of the neonates admitted to intensive care units receive sedatives or analgesics. There is significant variation between Spanish neonatal units as regards sedation and analgesia prescribing. Our results provide evidence on the "state of the art", and could serve as the basis of preparing clinical practice guidelines at a national level.
-
Multicenter Study
Assessment of a Stool Symptom Screener and Understanding the Opioid-Induced Constipation Symptom Experience.
Many patients with chronic opioid-induced constipation (OIC) seek treatment to relieve their symptoms. A symptom screener may be useful in identifying symptomatic OIC patients. ⋯ OIC patients understood this Stool Symptom Screener, and its content was relevant to this highly symptomatic patient sample. Pain and bloating may be considered as additional symptoms for future versions of the screener. An emerging conceptual model of the OIC experience, laxative use, and symptoms is presented.
-
Randomized Controlled Trial Multicenter Study
Development and Preliminary Validation of an Integrated Efficacy-Tolerability Composite Measure for the Evaluation of Analgesics.
The goal of this analysis was to develop and evaluate integrated measures of benefit and tolerability of analgesic drugs in clinical trials. We evaluated an efficacy-tolerability composite (ETC) measure combining different cutoff values for daily pain reduction (≥20%, ≥30%, or ≥50% pain reduction) and adverse events (AEs) (no AE, no or mild AEs, no or mild drug-related AEs). Nine ETC cutoff values (3 × 3) were tested using data from a randomized double-blind trial comparing tapentadol extended release (ER) (n = 310), oxycodone controlled release (CR) (n = 322), and placebo (n = 314) in subjects with chronic low back pain. ⋯ For all 9 ETC measures, validity was demonstrated by significant correlation of ETC scores with patients' Global Impression of change and with change from baseline in pain scores. Tapentadol ER ETC scores were statistically significantly higher than oxycodone CR ETC scores for 4 of the ETC measures. "No/mild drug-related AE and ≥20% pain reduction" demonstrated the best overall validity (correlation with patients' global impression of change) and responsiveness (discrimination between treatment groups), yielding a higher standardized effect size for tapentadol ER compared with placebo (0.19 [95% confidence interval: 0.031-0.346]) and with oxycodone CR (0.23 [95% confidence interval: 0.070-0.383]) than other cutoff values. Thus, we have identified herein a composite measure that seems to be a valid and responsive measure of the overall efficacy and tolerability of analgesics in clinical trials.