Chronic foot and leg ulcers are a common health problem worldwide. A mainstay of chronic ulcer therapy is sharp mechanical wound debridement requiring potent analgesia. In this prospective, controlled, single-centre, crossover design study, patients were assigned to either the administration of topical analgesia with 5% lidocaine/prilocaine cream or the inhalation of an analgesic 50% N O/O gas premix. Primary outcome parameter was level of pain at maximum wound depth during debridement as measured by a visual analogue scale. Secondary outcomes included level of pain after debridement, overall duration of treatment session, duration and completeness of debridement, and the patient's subjective perception of analgesic quality during debridement. Pain level increased from 0·60/0·94 (first/second debridement; baseline) to 1·76/2·50 (debridement) with 5% lidocaine/prilocaine and from 1·00/1·35 (baseline) to 3·95/3·29 (debridement) with 50% N O/O gas premix. Patient satisfaction was 90·48%/94·44% (first/second debridement) with topical 5% lidocaine/prilocaine analgesia and 90·48%/76·47% with the inhalation of 50% N O/O gas premix. Debridement was completed in a significantly higher percentage of 85·71%/88·89% (first/second debridement) with 5% lidocaine/prilocaine than with 50% N O/O gas premix (42·86%/58·82%) (odds ratio 6·7; P = 0·001). This study provides sound evidence that analgesia with topically administered 5% lidocaine/prilocaine cream is superior to the use of inhaled 50% N O/O gas premix in chronic leg ulcer debridement.
SUMMARY
In a double blind study the effect of phenobarbitone on neonatal hyperbilirubinaemia and the frequency of exchange transfusion was investigated. Newborn infants admitted were randomly assigned to one of two groups. The treated group comprised 56 and the control group 60 infants. Either placebo solution or phenobarbitone was injected i.m. at 8 hourly intervals for a total of 10 injections. The single dose varied between 1 mg and 5 mg according to weight. One exchange transfusion had to be performed in the treated and 11 in the control group. This difference is statistically significant. Serumbilirubin concentrations from the 4th day on were significantly lower in the treated infants than in controls.
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