Articles: nausea.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
[Intravenous administration of ondansetron vs. metoclopramide for the prophylaxis of postoperative nausea and vomiting].
This randomized, double-blind, multicentre, parallel-group study compared the efficacy and safety of an intravenous dose of ondansetron 4 mg for the prevention of postoperative nausea and vomiting (PONV) with metoclopramide 10 mg and placebo in patients undergoing major gynaecological surgery. A total of 1044 patients (465 ondansetron, 462 metoclopramide, 117 placebo) received study medication immediately prior to induction of anaesthesia and were included in the analysis of data. The proportion of patients experiencing no emesis and no nausea or provided with rescue antiemetic medication, the number of emetic episodes, and the duration and severity of nausea were recorded during the 24-h period after recovery. ⋯ Significantly fewer patients in the ondansetron group required rescue medication or were withdrawn due to treatment failure (P < 0.05). In the ondansetron group the total number of emetic episodes, the median time to the first emetic episode or treatment failure, and the duration and severity of nausea were reduced significantly compared with metoclopramide or placebo (P < 0.05). The safety profile was similar for each treatment group.
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Multicenter Study Clinical Trial Controlled Clinical Trial
Control of nausea and vomiting by Navoban (tropisetron) in 131 children receiving cytotoxic chemotherapy.
One hundred and thirty-one children with a median age of 5 years were administered Navoban (tropisetron), a selective antagonist of the serotonin receptor (5-HT3), dosed once daily at 0.2 mg/kg (with a maximum of 5 mg daily) in a study aimed at evaluating the prevention of nausea and vomiting induced by anti-cancer chemotherapy. The most common malignancy (in 49% of patients) was acute lymphocytic leukaemia. Patients received Navoban during one or more courses of emetogenic chemotherapy for a total of 455 courses administered intravenously or intravenously and intrathecally (IV + IT). ⋯ Ninety-six per cent of the intravenous chemotherapy group and 97% of the IV + IT chemotherapy group had a complete (70% and 55% respectively) or partial (26% and 42% respectively) response during the first 24-hour period of the first course in which Navoban was used. The second and subsequent courses yielded similar percentages. Delayed emesis was observed mainly during those courses employing the most emetogenic chemotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)
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Anesthesia and analgesia · Nov 1994
Randomized Controlled Trial Multicenter Study Clinical TrialOndansetron prevents postoperative nausea and vomiting in women outpatients.
Three doses of intravenous (i.v.) ondansetron, 1 mg, 4 mg, and 8 mg, were compared to placebo for their antiemetic effect and safety. The drugs or placebo were administered in a double-blind manner, prophylactically to 589 women undergoing elective outpatient surgical procedures under nitrous oxide opioid-based general endotracheal anesthesia. In the postanesthesia care unit, the number of emetic episodes, periodic assessments of nausea severity using an 11-point scale (0 = no nausea; 10 = worst nausea), vital signs, and adverse events were collected by an independent observer for 2 h. ⋯ Heart rate, blood pressure, respiratory rate, and laboratory safety variables were not different among the groups. Ondansetron did not prolong awakening time. This study indicates that ondansetron is a safe and effective prophylactic antiemetic for women who have outpatient surgery under nitrous oxide opioid-based general anesthesia.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Dose-finding study of tropisetron in cisplatin-induced nausea and vomiting.
The purpose of these two studies was to define the optimal therapeutic dose of the 5-HT3 receptor antagonist tropisetron (Navoban, ICS 205-930) in cisplatin-induced nausea and vomiting. ⋯ Thus, a single dose of tropisetron provides 24-hour protection against cisplatin-induced nausea and vomiting and is well tolerated. These studies do not allow a firm conclusion but suggest that 2 mg may be subtherapeutic and that 5 mg is as effective as higher doses.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin.
To assess the antiemetic effects and safety profile of four different doses of granisetron (Kytril; SmithKline Beecham Pharmaceuticals, Philadelphia, PA) when administered as a single intravenous (IV) dose for prophylaxis of cisplatin-induced nausea and vomiting. ⋯ A single 10-, 20-, or 40-micrograms/kg dose of granisetron was effective in controlling vomiting in 57% to 60% of patients who received cisplatin at doses greater than 81 mg/m2 and totally prevented vomiting in 40% to 47% of patients. There were no statistically significant differences in efficacy between the 10-micrograms/kg dose and the 20- and 40-micrograms/kg doses. Granisetron was well tolerated at all doses.