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      Does the Routine Prophylactic Use of Antiemetics Affect the Incidence of Postdischarge Nausea and Vomiting following Ambulatory Surgery? : A Systematic Review of Randomized Controlled Trials

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          Language bias in randomised controlled trials published in English and German.

          Some randomised controlled trials (RCTs) done in German-speaking Europe are published in international English-language journals and others in national German-language journals. We assessed whether authors are more likely to report trials with statistically significant results in English than in German. We studied pairs of RCT reports, matched for first author and time of publication, with one report published in German and the other in English. Pairs were identified from reports round in a manual search of five leading German-language journals and from reports published by the same authors in English found on Medline. Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors' identities, affiliations, and other characteristics of trial reports. Main study endpoints were selected by two investigators who were unaware of trial results. Our main outcome was the number of pairs of studies in which the levels of significance (shown by p values) were discordant. 62 eligible pairs of reports were identified but 19 (31%) were excluded because they were duplicate publications. A further three pairs (5%) were excluded because no p values were given. The remaining 40 pairs were analysed. Design characteristics and quality features were similar for reports in both languages. Only 35% of German-language articles, compared with 62% of English-language articles, reported significant (p < 0.05) differences in the main endpoint between study and control groups (p = 0.002 by McNemar's test). Logistic regression showed that the only characteristic that predicted publication in an English-language journal was a significant result. The odds ratio for publication of trials with significant results in English was 3.75 (95% CI 1.25-11.3). Authors were more likely to publish RCTs in an English-language journal if the results were statistically significant. English language bias may, therefore, be introduced in reviews and meta-analyses if they include only trials reported in English. The effort of the Cochrane Collaboration to identify as many controlled trials as possible, through the manual search of many medical journals published in different languages will help to reduce such bias.
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            Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design.

            Despite intensive research, the main causes of postoperative nausea and vomiting (PONV) remain unclear. We sought to quantify the relative importance of operative, anaesthetic and patient-specific risk factors to the development of PONV. We conducted a randomized controlled trial of 1180 children and adults at high risk for PONV scheduled for elective surgery. Using a five-way factorial design, we randomly assigned subjects by gender who were undergoing specific operative procedures, to receive various combinations of anaesthetics, opioids, and prophylactic antiemetics. Of the 1180 patients, 355 (30.1% 95% CI (27.5-32.7%)) had at least one episode of postoperative vomiting (PV) within 24 h post-anaesthesia. In the early postoperative period (0-2 h), the leading risk factor for vomiting was the use of volatile anaesthetics, with similar odds ratios (OR (95% CI)) being found for isoflurane (19.8 (7.7-51.2)), enflurane (16.1 (6.2-41.8)) and sevoflurane (14.5 (5.6-37.4)). A dose-response relationship was present for the use of volatile anaesthetics. In contrast, no dose response existed for propofol anaesthesia. In the delayed postoperative period (2-24 h), the main predictors were being a child (5.7 (3.0-10.9)), PONV in the early period (3.4 (2.4-4.7)) and the use of postoperative opioids (2.5 (1.7-3.7)). The influence of the antiemetics was considerably smaller and did not interact with anaesthetic or surgical variables. Volatile anaesthetics were the leading cause of early postoperative vomiting. The pro-emetic effect was larger than other risk factors. In patients at high risk for PONV, it would therefore make better sense to avoid inhalational anaesthesia rather than simply to add an antiemetic, which may still be needed to prevent or treat delayed vomiting.
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              Cost-effectiveness of prophylactic antiemetic therapy with ondansetron, droperidol, or placebo.

              In an era of growing economic constraints on healthcare delivery, anesthesiologists are increasingly expected to understand cost analysis and evaluate clinical practices. Postoperative nausea and vomiting (PONV) are distressing for patients and may increase costs in an ambulatory surgical unit. The authors compared the cost-effectiveness of four prophylactic intravenous regimens for PONV: 4 mg ondansetron, 0.625 mg droperidol, 1.25 mg droperidol, and placebo. Adult surgical outpatients at high risk for PONV were studied. Study drugs were administered intravenously within 20 min of induction of nitrous oxide-isoflurane or enflurane anesthesia. A decision-tree analysis was used to group patients into 12 mutually exclusive subgroups based on treatment and outcome. Costs were calculated for the prevention and treatment of PONV. Cost-effectiveness analysis was performed for each group. Two thousand sixty-one patients were enrolled. Efficacy data for study drugs have been previously reported, and the database from that study was used for pharmacoeconomic analysis. The mean-median total cost per patient who received prophylactic treatment with 4 mg ondansetron, 0.625 mg droperidol, 1.25 mg droperidol, and placebo were $112 or $16.44, $109 or $0.63, $104 or $0.51, and $164 or $51.20, respectively (P = 0.001, active treatment groups vs. placebo). The use of a prophylactic antiemetic agent significantly increased patient satisfaction (P < 0.05). Personnel costs in managing PONV and unexpected hospital admission constitute major cost components in our analysis. Exclusion of nursing labor costs from the calculation did not alter the overall conclusions regarding the relative costs of antiemetic therapy. The use of prophylactic antiemetic therapy in high-risk ambulatory surgical patients was more effective in preventing PONV and achieved greater patient satisfaction at a lower cost compared with placebo. The use of 1.25 mg droperidol intravenously was associated with greater effectiveness, lower costs, and similar patient satisfaction compared with 0.625 mg droperidol intravenously and 4 mg ondansetron intravenously.
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                Author and article information

                Journal
                Anesthesiology
                Anesthesiology
                Ovid Technologies (Wolters Kluwer Health)
                0003-3022
                2003
                August 2003
                : 99
                : 2
                : 488-495
                Article
                10.1097/00000542-200308000-00033
                73a1a95f-3603-423a-873c-9a38b8360489
                © 2003
                History

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