The safety profile of ProHance in special populations was evaluated by analyzing data extracted from the database of phase I-III studies which included data on 2,656 ProHance injections of which 119 in pediatric patients, 814 in elderly patients and 30 in patients with varying degrees of renal impairment (moderate, severe or end stage requiring hemodialysis). ProHance was administered at doses ranging from 0.1 mmol/kg to 0.3 mmol/kg and was found to be safe in all patient populations irrespective of age and of pre-existing renal impairment. There appeared to be no correlation between incidence of adverse events and dose level in these special populations and the higher dose level of 0.3 mmol/kg could be safely administered also to patients with end stage renal disease requiring hemodialysis, from whom the contrast medium was rapidly and efficiently dialysed.
SummaryIn a randomised, double-blinded, two-centre trial we evaluated the effect of a microbiological filter (SuporÒ, Pall Life Sciences) on propofol injection pain. We studied 336 unpremedicated adult patients, who graded pain experienced during induction of anaesthesia with propofol on a 4-point verbal rating scale. Use of the microfilter reduced both the incidence and severity of propofol injection pain (p < 0.001). Incidence of severe pain in the filter group was 2.4% compared with 16.6% in the control group. Overall, 33.7% in the filter group experienced pain compared with 62.1% in the control group. A microbiological filter may provide a non-pharmacological alternative to a lidocaine ⁄ propofol mixture for reducing injection pain. It would also reduce the risk of any glass and bacterial contamination.
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