Articles: nausea.
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Support Care Cancer · Jan 1997
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy.
The potent serotonin receptor (5-HT3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of dolasetron mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (> or = 80 mg/m2) cisplatin. ⋯ In conclusion, dolasetron mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of dolasetron mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg dolasetron mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.
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Acta Anaesthesiol Belg · Jan 1997
Randomized Controlled Trial Multicenter Study Clinical TrialSingle i.v. bolus dose of ondansetron in the prevention of postoperative nausea and emesis.
In this placebo controlled, double blind multicentre study, the efficacy and safety of a single i.v. bolus dose of ondansetron 4 mg were evaluated in the prevention of postoperative nausea and vomiting (PONV), which remains one of the most unpleasant side effects experienced by patients postoperatively. The study population included patients having general anesthesia and undergoing major gynecological or elective abdominal surgery by laparoscopy. ⋯ Several factors appeared to be associated with an increased risk of developing PONV, namely gender (female), type of surgery (gynecological), experience of previous PONV and duration of anesthesia; the use of propofol was not a significant factor. Ondansetron was well tolerated, with no side effect being reported as a significant problem.
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Paediatric anaesthesia · Jan 1997
Randomized Controlled Trial Multicenter Study Clinical TrialOndansetron reduces nausea and vomiting after paediatric adenotonsillectomy.
The efficacy, safety and resource implications of a single intravenous dose of ondansetron (0.1 mg.kg-1, maximum 4 mg) were assessed in a multinational, multicentre, randomized, double-blind, placebo-controlled trial of 427 children aged 1-12 years, undergoing tonsillectomy with/without adenoidectomy. Emesis (retching and/or vomiting) and nausea were analysed separately. Significantly more ondansetron-treated children had no episodes of emesis (127/212 (60%) vs 100/215 (47%); P = 0.004) and experienced no postoperative nausea (135/211 (64%) vs 108/213 (51%); P = 0.004) in the first 24 h. ⋯ Significantly fewer ondansetron-treated children were rescued or withdrawn from the study (5% vs 10%; P = 0.042). Fewer ondansetron-treated patients required nursing intervention (34% vs 45%; P = 0.007) and the average intervention time was significantly shorter (4.6 vs 8.1 minutes; P = 0.001). Resources used to manage PONV were significantly reduced by ondansetron (43% vs 57%; P = 0.014).
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomised, double-blind, parallel-group study to compare the efficacy and safety of ondansetron (GR38032F) plus dexamethasone with metoclopramide plus dexamethasone in the prophylaxis of nausea and emesis induced by carboplatin chemotherapy.
A double-blind, parallel-group study in 189 ovarian cancer patients compared the efficacy of ondansetron 8 mg i.v. (OND) and metoclopramide 60 mg i.v. (MET) both in combination with dexamethasone 20 mg i.v. in the prevention of carboplatin-induced emesis. On day 1, complete or major control of emesis (0-2 emetic episodes) was observed in 97% patients from the OND group compared with 74% patients from the MET group (p < 0.001). Similarly, a worst-day analysis over days 1-3 showed complete or major control of emesis in 87% patients (OND) compared wth 66% patients (MET) (p < 0.001). ⋯ Fewer patients from the OND group (13%) reported adverse events compared with the MET group (21%). Extrapyramidal type symptoms were observed in 6 (6%) patients from the MET group (paraesthesia, involuntary movement of the jaw and tongue, and restlessness), compared with none from the OND group. Ondansetron plus dexamethasone is a highly effective and well-tolerated treatment and is significantly superior to metoclopramide plus dexamethasone in the prevention of carboplatin-induced emesis.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A multicentre, double-blind study comparing placebo, ondansetron and ondansetron plus dexamethasone for the control of cisplatin-induced delayed emesis. Ondansetron Delayed Emesis Study Group.
The purpose of this study was to investigate the efficacy and safety of oral ondansetron, given alone or in combination with dexamethasone in the control of cisplatin-induced delayed emesis. ⋯ In contrast to some previous investigations, in this study, ondansetron alone appears to have a minor role in the control of cisplatin-induced delayed emesis and nausea. In conclusion, the combination of oral ondansetron plus dexamethasone is superior to ondansetron and to placebo.