British journal of anaesthesia
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This study details all incidents involving medical devices used in anaesthesia and intensive care reported to the relevant authorities in France in 1998. There were 1004 reports during that year. Incidents were classified as serious (harmful to patients) in 11% of cases; death resulted in 2% of cases. ⋯ User errors, quality control problems during production of the device and design faults were the three main causes. The problems identified during the study period enabled the faulty medical devices to be improved in 12-44% of cases. We conclude that post-marketing vigilance is a useful way of improving the quality of medical devices.
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Randomized Controlled Trial Comparative Study Clinical Trial
Evaluation of pre-emptive intramuscular phenylephrine and ephedrine for reduction of spinal anaesthesia-induced hypotension during Caesarean section.
Pre-emptive intramuscular (i.m.) vasopressors were evaluated in 108 patients undergoing elective Caesarean section under spinal anaesthesia, assigned to four groups in a randomized, double-blind, placebo-controlled study. Group 1 received pre-emptive phenylephrine 4 mg i.m., group 2 received phenylephrine 2 mg i.m., group 3 received ephedrine 45 mg i.m., while controls received an i.m. injection of saline, all given immediately after induction of spinal anaesthesia. Hypotension was defined as a 25% decrease in mean arterial pressure (MAP). ⋯ The phenylephrine 4 mg and ephedrine 45 mg groups had a significantly lower percentage reduction in MAP (-21 (SD 14)% and -22 (14)%) compared with controls (-32 (18)%, P=0.04). They also had a lower total dose of rescue i.v. ephedrine (15.7 (15.7) mg and 15.8 (15.6) mg) compared with controls (28.8 (20.6) mg, P=0.02). We conclude that pre-emptive i.m. phenylephrine 4 mg and ephedrine 45 mg reduce the severity of hypotension and the total dose of rescue i.v. ephedrine during spinal anaesthesia for Caesarean section.
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Randomized Controlled Trial Comparative Study Clinical Trial
I.v. ketoprofen for analgesia after tonsillectomy: comparison of pre- and post-operative administration.
We have evaluated the safety and efficacy of ketoprofen during tonsillectomy in 106 adults receiving standardized anaesthesia. Forty-one patients received ketoprofen 0.5 mg kg(-1) at induction ('pre' ketoprofen group) and 40 patients after surgery ('post' ketoprofen group), in both cases followed by a continuous ketoprofen infusion of 3 mg kg(-1) over 24 h; 25 patients received normal saline (placebo group). Oxycodone was used for rescue analgesia. ⋯ Patients in the placebo group received significantly more oxycodone doses than patients in the two ketoprofen groups (P=0.001). Two patients (5%) in the 'pre' ketoprofen group and one (3%) in the 'post' ketoprofen group had post-operative bleeding between 4 and 14 h. All three patients required electrocautery.