Articles: nausea.
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Support Care Cancer · Sep 1999
Randomized Controlled Trial Multicenter Study Clinical TrialA multicenter, double-blind, randomized comparison of oral ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with highly emetogenic chemotherapy. S3AA3012 Study Group.
The objectives of this study were to compare the efficacy and safety of orally administered ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with high-dose cisplatin-based chemotherapy (cisplatin > or = 50 mg/m2). This was a randomized, parallel-group, double-blind study conducted in North America. It was planned that all patients would receive one of the following orally administered ondansetron treatments 30 min before starting cisplatin dosing (administered over < or = 3 h): 8 mg b.i.d. with 8 h between doses (124 patients), 24 mg q.d. (116 patients), and 32 mg q.d. (117 patients). ⋯ Complete control of nausea (no nausea, no rescue, no withdrawal) occurred in more patients in the ondansetron 24 mg q.d. group (64/114, 56%) than in the ondansetron 8 mg b.i.d. group (43/121, 36%) or in the ondansetron 32 mg group (55/117, 50%). These results demonstrate that following highly emetogenic cisplatin-based chemotherapy (> or =2 50 mg/m2), oral ondansetron 24 mg q.d. is more effective than 8 mg b.i.d. for overall control of nausea, and at least as effective if not more effective in the control of acute vomiting than 8 mg b.i.d. or 32 mg q.d. Ondansetron 24 mg q.d. was well tolerated, and no new or unexpected adverse events were identified.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effects of anti-emetic drug (tropisetron) on quality of life during chemotherapy: use of a diary-type questionnaire and application of summary measures for assessment in a randomized, multicentre study. Joint Research Group for Tropisetron Double-Blind Comparative Study.
The role of tropisetron as an anti-emetic drug in the prevention of delayed nausea and vomiting remains unclear. Therefore, effectiveness of tropisetron in patients receiving cancer chemotherapy was evaluated by application of summary measures using a quality of life (QOL) questionnaire. The diary-type QOL self-rating questionnaire was constituted by seven scales. ⋯ All scales, except social wellbeing changed immediately in both groups and reached a nadir on days 2-3, after that returning to the control levels during 2 weeks after cisplatin treatment. Group T was significantly better than group P in physical wellbeing, mental wellbeing, functional wellbeing and global QOL scores summarized by area under the curve and Difmax (maximum differences of QOL scales' score from the best score throughout the entire period). These results indicate that continuous administration of tropisetron could contribute to preventing patient QOL influenced by cisplatin treatment, and the combined use of summary measures may be useful for the evaluation of QOL in cancer clinical trial.
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Randomized Controlled Trial Clinical Trial
Study of efficacy and tolerability of tropisetron in the prevention of cisplatin induced nausea and vomiting.
The efficacy and tolerability of tropisetron alone or in combination with dexamethasone was studied in an open randomised trial in a total of 30 patients undergoing cisplatin based chemotherapy. Patients received tropisetron 5 mg plus dexamethasone 8 mg i.v. on day 1 followed by tropisetron 5 mg p.o. plus dexamethasone 4 mg orally bid on day 2-6 (group I) versus tropisetron 5 mg p.o. alone on day 2-6 (group II). No demographic difference among the groups was observed. ⋯ The most frequent side effects were headache, stupor and diarrhea. In conclusion, tropisetron is an effective and well tolerated antiemetic for preventing acute and delayed emesis in cisplatin-based chemotherapy. In addition, combining dexamethasone improved the efficacy in particular in controlling delayed emesis.
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Clinical therapeutics · Jul 1999
Randomized Controlled Trial Multicenter Study Clinical TrialIntravenous ondansetron for the control of opioid-induced nausea and vomiting. International S3AA3013 Study Group.
This randomized, double-masked, placebo-controlled, multicenter trial was conducted in 9 countries to assess the safety and efficacy of 2 doses of intravenous ondansetron (8 and 16 mg) for the control of opioid-induced nausea and vomiting. A total of 2574 nonsurgical patients who presented with pain requiring treatment with an opioid analgesic agent participated in this trial. The most common presenting painful condition was back or neck pain, reported by approximately one third of patients. ⋯ Significantly more patients who received ondansetron 16 mg compared with placebo were satisfied/very satisfied on 2 of 4 satisfaction questions. In conclusion, based on the observed incidence of opioid-induced nausea and vomiting in this study, it may be more appropriate to treat symptoms on occurrence rather than administering antiemetic agents prophylactically. The results of this study demonstrate that intravenous ondansetron in doses of 8 or 16 mg is an effective antiemetic agent for the control of opioid-induced nausea and vomiting in nonsurgical patients requiring opioid analgesia for pain.
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Anesthesia and analgesia · Jul 1999
Randomized Controlled Trial Comparative Study Clinical TrialThe prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline.
The aim of this study was to evaluate the prophylactic effect of dexamethasone on postoperative nausea and vomiting (PONV) in women undergoing thyroidectomy. Droperidol and saline served as controls. One hundred twenty women (n = 40 in each of three groups) undergoing thyroidectomy under general anesthesia were enrolled in this randomized, double-blinded, placebo-controlled study. Immediately before the induction of anesthesia, Group 1 received IV dexamethasone 10 mg, whereas Groups 2 and 3 received IV droperidol 1.25 mg and saline, respectively. We found that both dexamethasone and droperidol significantly decreased the total incidence of PONV compared with saline, with an incidence of 32%, 35%, and 76%, respectively (P<0.01; Group 1 versus Group 3, Group 2 versus Group 3). Patients who received droperidol, however, reported a higher intensity of sore throat and a more frequent incidence of restlessness than those who received dexamethasone. We conclude that, although both dexamethasone and droperidol are effective as prophylactic antiemetics in women undergoing thyroidectomy, droperidol produces more side effects. ⋯ We compared the prophylactic administration of dexamethasone to prevent nausea and vomiting with droperidol and saline in women undergoing thyroidectomy. Both dexamethasone and droperidol significantly reduced postoperative nausea and vomiting, but droperidol produced more side effects, which suggests that dexamethasone is a useful treatment in these patients.