Lancet
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Randomized Controlled Trial Clinical Trial
Intraperitoneal local anaesthetic for shoulder pain after day-case laparoscopy.
Laparoscopy is frequently associated with postoperative shoulder pain that may last several days. We have assessed the analgesic effect of intraperitoneal local anaesthetics during day-case diagnostic laparoscopy. 80 young women were randomly assigned to one of four groups of 20 patients each: group 1, no peritoneal administration; group 2, 80 ml saline injected under direct vision in the right subdiaphragmatic area at the start of the procedure; group 3, 80 ml 0.5% lignocaine with adrenaline (320,000 dilution); group 4, 0.125% bupivacaine with adrenaline (800,000 dilution). ⋯ Analgesic requirements were greater in the non-treatment groups than in the local anaesthetic groups. Intraperitoneal local anaesthetic administration during laparoscopy is both a non-invasive and an efficient method of reducing the intensity of scapular pain.
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Randomized Controlled Trial Clinical Trial
Prevention of travellers' diarrhoea by oral B-subunit/whole-cell cholera vaccine.
B-subunit/whole-cell cholera vaccine (BS-WC) has been shown to give Bangladeshi mothers and children only 3 months' protection against severe diarrhoea due to enterotoxigenic Escherichia coli (ETEC). Since a long-lasting effect is not necessary for protection against travellers' diarrhoea, a prospective double-blind study was conducted among tourists who went to Morocco from Finland. 307 tourists received two oral doses of BS-WC, whereas 308 controls received a placebo before departure. A research team went out with tourists and a laboratory for enteric pathogens was set up on location. ⋯ The protection was better for mixed infections (65%, p = 0.016). The protective efficacy against a combination of ETEC and any other pathogen was 71% (p = 0.02), and that against ETEC plus Salmonella enterica even better at 82% (p = 0.01). Partial protection against travellers' diarrhoea is thus obtainable by active immunisation with BS-WC.
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Randomized Controlled Trial Comparative Study Clinical Trial
Child mortality after high-titre measles vaccines: prospective study in Senegal.
The use of Edmonston-Zagreb high-titre (EZ-HT) vaccine at age 6 months has been recommended for countries in which measles before the age of 9 months is a substantial cause of death, but little is known about the long-term effects of high-titre live measles vaccines given early in life. In a randomised vaccine trial in a rural area of Senegal, children were randomly assigned at birth to three vaccine groups: EZ-HT at 5 months (n = 336); Schwarz high-titre (SW-HT) at 5 months (n = 321); and placebo at 5 months followed by standard low-titre Schwarz vaccine at 10 months (standard: n = 358). All children were prospectively followed for 24-39 months in a well-established demographic surveillance system. ⋯ The three vaccine groups were comparable as regards various social, family, and health characteristics, and there was no difference in mortality between children who received the standard vaccine and those who were eligible for the trial but did not take part for various reasons. The higher risk of death in the two high-titre vaccine groups remained significant in multivariate analyses. These findings suggest a need to reconsider the use of high-titre measles vaccines early in life in less developed countries.
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Randomized Controlled Trial Clinical Trial
Randomised, controlled trial of effectiveness of ampicillin in mild acute respiratory infections in Indonesian children.
The recommended treatment for mild acute respiratory infections (ARI) in children is supportive care only, but many physicians, especially in developing countries, continue to prescribe antibiotic treatment because they believe it prevents progression to more severe ARI. To find out whether ampicillin treatment conferred any benefit over supportive care alone, a randomised, controlled trial was carried out among 889 children (under 5 years) with mild ARI in Indonesia. 447 were randomly allocated ampicillin (25-30 mg/kg body weight three times daily for 5 days) plus supportive care (continued breastfeeding, clearing of the nose, and paracetamol to control fever); 442 were allocated supportive care only. The treatment groups were almost identical after randomisation in terms of age, sex, level of parental education, history of measles immunisation, and fever. ⋯ At the 2-week follow-up, the percentages cured were 62% (277) in the ampicillin group and 58% (256) in the control group; 14% of both groups had progressed to moderate ARI; and 24% (107) and 28% (123), respectively, still had mild ARI. None of the differences in outcome between the ampicillin and control groups was statistically significant. Thus, ampicillin plus supportive care offers no benefit over supportive care alone for treatment of mild ARI in young Indonesian children.
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Randomized Controlled Trial Clinical Trial
Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters.
More than 90% of all intravascular device-related septicaemias are due to central venous or arterial catheters. To assess the efficacy of cutaneous antisepsis to prevent catheter-associated infection, we prospectively studied three antiseptics for disinfection of patients' central venous and arterial catheter insertion sites in a surgical intensive care unit. 668 catheters were randomised to 10% povidone-iodine, 70% alcohol, or 2% aqueous chlorhexidine disinfection of the site before insertion and for site care every other day thereafter. ⋯ Of the 14 infusion-related bacteraemias (4 due to contaminated infusate or catheter hub, 10 due to infected catheters), 1 was in the chlorhexidine group and 13 were in the other two groups (odds ratio 0.16, p = 0.04). We conclude that use of 2% chlorhexidine, rather than 10% povidone-iodine or 70% alcohol, for cutaneous disinfection before insertion of an intravascular device and for post-insertion site care can substantially reduce the incidence of device-related infection.