Articles: nausea.
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Seminars in oncology · Dec 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialSingle-dose ondansetron for the prevention of cisplatin-induced emesis: efficacy results.
Ondansetron 0.15 mg/kg, given intravenously (IV) every 4 hours for three doses, has replaced metoclopramide as standard antiemetic therapy for patients receiving cisplatin-based chemotherapy. Several clinical observations suggested that ondansetron may be effective when given in a single dose: (1) demonstration of efficacy over a wide dose range, (2) similar efficacy with dosing intervals of 2, 4, 6, and 8 hours, and (3) efficacy of single-dose regimens with high-dose metoclopramide and other 5-hydroxytryptamine3 antagonists. In this study, patients receiving cisplatin-based chemotherapy were randomized to receive one of three ondansetron dosing regimens: ondansetron 0.15 mg/kg IV every 4 hours x 3 (standard schedule), ondansetron 32 mg IV x 1, or ondansetron 8 mg IV x 1. ⋯ All three schedules were well tolerated. Ondansetron 32 mg given prior to cisplatin is superior to a single 8-mg dose and is at least as effective, if not superior to, the standard three-dose schedule (0.15 mg/kg every 4 hours). On the basis of these data, ondansetron 32 mg should be considered standard therapy in patients receiving cisplatin-based chemotherapy and should be the schedule with which new antiemetics and alternate dosing schedules are compared.
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialOndansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.
The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. ⋯ The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialProphylactic intravenous ondansetron in female outpatients undergoing gynaecological surgery: a multicentre dose-comparison study.
The efficacy and safety of prophylactic intravenous ondansetron in preventing postoperative nausea and vomiting was investigated in a randomized, stratified, double-blind, placebo-controlled, dose-comparison study of 580 ASA physical class I and II female outpatients undergoing gynaecological surgery and receiving general anaesthesia. Patients received either ondansetron 1, 4 or 8 mg, or placebo i.v. immediately prior to a standardized technique for induction and maintenance of anaesthesia. All patients were intubated and received nitrous oxide and a narcotic. ⋯ Ondansetron was generally well tolerated, as evidenced by an adverse event, laboratory safety, and vital sign profile similar to placebo. Ondansetron 4 mg was found to be the optimal prophylactic i.v. dose for female outpatients over the entire 24 h postoperative period. Higher doses may offer an added benefit in some patients, such as those with a history of nausea and vomiting following general anaesthesia.
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Eur J Anaesthesiol Suppl · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialOral ondansetron in the prevention of postoperative nausea and vomiting.
The effect of three times daily oral ondansetron in preventing postoperative nausea and vomiting was investigated in two randomized, double-blind, placebo-controlled, multi-centre studies. The first study compared ondansetron 1, 8 and 16 mg to placebo, and the second study compared 8 mg ondansetron to placebo. Both studies included ASA Class I-III female patients about to undergo major abdominal gynaecological surgery or vaginal hysterectomy. ⋯ Side-effects mainly consisted of constipation, headache, and asymptomatic elevation of liver enzymes. The incidence of side-effects was similar in ondansetron- and placebo-treated patients. There appeared to be no clinically important benefit of the 16 mg three times daily ondansetron regimen over the 8 mg three times daily dose, therefore 8 mg three times daily is recommended as the optimal oral dose in the prevention of postoperative nausea and vomiting.
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Gan To Kagaku Ryoho · Oct 1992
Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial[Evaluation of SN-307 (ondansetron), given intravenously in the treatment of nausea and vomiting caused by anticancer drugs including cisplatin--a placebo-controlled, double-blind comparative study].
Clinical usefulness of ondansetron as an antiemetic for the treatment of nausea and vomiting induced by anticancer drugs including cisplatin (> or = 50 mg/m2) was evaluated by a multi-institutional, double-blind comparative study with placebo with inpatients with various malignancies. In this study, efficacy, safety and usefulness of single dose of ondansetron (4 mg) or placebo (physiological saline), given intravenously for initial nausea and vomiting were observed for 24 hours after treatment. Clinically, very effective or effective response was seen in 64% (16/25) of the group O (ondansetron) and 5.9% (1/17) of the group P (placebo). ⋯ General safety assessment was considered "safe" in 100% of both group O and group P, and there was no statistical difference between two groups. Usefulness was considered as "useful" in 64% (16/25) of group O and 6.3% (1/16) of group P, and O was significantly better than group P (p < 0.001) level. In conclusion, ondansetron provides a safe and effective antiemetic measure when employed therapeutically against nausea and vomiting induced by regimens including cisplatin.