Clinical drug investigation
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Randomized Controlled Trial Multicenter Study Comparative Study
Ketoprofen versus paracetamol (acetaminophen) or ibuprofen in the management of fever: results of two randomized, double-blind, double-dummy, parallel-group, repeated-dose, multicentre, phase III studies in children.
Fever is a common symptom in children and one of the major concerns of parents of younger and preschool-age children. To compare the efficacy and safety of ketoprofen with that of paracetamol (acetaminophen) and ibuprofen in the treatment of febrile conditions in children. Two prospective, randomized, double-blind, double-dummy, repeated-dose, multicentre, phase III studies with two parallel groups in each study were conducted in primary-care outpatient clinics. ⋯ Use of ketoprofen was not associated with any increased risk of adverse events compared with the two reference compounds. Ketoprofen 0.5 mg/kg appeared to be equivalent to the standard antipyretic doses of the reference products ibuprofen 5 mg/kg and paracetamol 15 mg/kg. Ketoprofen at the 0.5 mg/kg dose should be an effective and safe option for symptomatic management of fever in children.
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Randomized Controlled Trial Comparative Study
Effects of sugammadex doses up to 32 mg/kg alone or in combination with rocuronium or vecuronium on QTc prolongation: a thorough QTc study.
Sugammadex reverses the effects of rocuronium- and vecuronium-induced neuromuscular blockade, which are achieved by encapsulation. It is known that some non-antiarrhythmic drugs have the potential to delay cardiac repolarization and it is therefore recommended that the effects of all new drugs on the QT interval are assessed. ⋯ Based on the results of this study of healthy subjects, it can be concluded that sugammadex alone or in combination with rocuronium or vecuronium is not associated with QTc prolongation.
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Randomized Controlled Trial
Safety, tolerability and pharmacokinetics of sugammadex using single high doses (up to 96 mg/kg) in healthy adult subjects: a randomized, double-blind, crossover, placebo-controlled, single-centre study.
Sugammadex facilitates rapid reversal of rocuronium- and vecuronium-induced neuromuscular blockade. This study aimed to evaluate the safety, tolerability and pharmacokinetics of high doses of sugammadex (up to 96 mg/kg) in healthy subjects. ⋯ High doses of sugammadex (up to 96 mg/kg) were well tolerated in 12 of the 13 subjects. One male subject experienced several adverse events associated with a probable hypersensitivity reaction to sugammadex. Pharmacokinetics were dose linear over the range 32-96 mg/kg, with elimination predominantly via the renal route.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of Tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: a randomized, double-blind, placebo- and active-controlled phase III study.
Tapentadol is a novel, centrally acting analgesic with mu-opioid receptor agonist and norepinephrine reuptake inhibitor activity. ⋯ treatment with Tapentadol ER 100-250 mg twice daily or oxycodone HCl CR 20-50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with Tapentadol ER than with oxycodone CR.
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Randomized Controlled Trial Comparative Study
Addition of dexmedetomidine or lornoxicam to prilocaine in intravenous regional anaesthesia for hand or forearm surgery: a randomized controlled study.
Intravenous regional anaesthesia (IVRA) is a simple and cost-effective technique that is ideally suited for surgery involving the distal arm. This study compared the effect of lornoxicam or dexmedetomidine in IVRA with prilocaine in patients who underwent hand or forearm surgery. M ethods: This randomized, double-blind study enrolled 75 patients scheduled for hand or forearm surgery. IVRA was achieved with 2% prilocaine 3 mg/kg in the control group (n=25), 2% prilocaine 3 mg/kg plus dexmedetomidine 0.5 microg/kg in the dexmedetomidine group (n=25), and 2% prilocaine 3 mg/kg plus lornoxicam 8 mg in the lornoxicam group (n=25). In all groups, 0.9% NaCl solution was added to make up a total volume of 40 mL. Sensory and motor block onset and recovery times, haemodynamic variables, visual analogue scale (VAS) pain and sedation scores, duration of analgesia, total analgesic consumption over 24 hours, adverse effects and quality of anaesthesia were recorded. ⋯ Addition of dexmedetomidine or lornoxicam to prilocaine in IVRA decreased VAS pain scores, improved anaesthesia quality and decreased analgesic requirement. We suggest that addition of dexmedetomidine or lornoxicam at the doses used in this study to IVRA with prilocaine in this setting can be useful without causing adverse effects. No hypotension, bradycardia or hypoxia requiring treatment was seen in any of the patients. Addition of dexmedetomidine had a more potent effect, shortening sensory block onset time and prolonging sensory block recovery time more than lornoxicam.