Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The management of chemotherapy induced emesis presents a major difficulty in the paediatric population. Ondansetron is a 5-HT3 antagonist and its antiemetic properties have been established in adults receiving chemotherapy. Experience in the treatment of children, however, is limited. There is no standard comparative antiemetic in paediatric practice, so this European, multi-centred study aimed to assess the clinical efficacy and safety of ondansetron in a large cohort of children receiving a range of emetogenic chemotherapy regimens for malignant disease. Two hundred patients were entered into the study, of whom 183 fulfilled entry criteria. Forty per cent (10/25) of patients receiving cisplatin, 68% (27/40) receiving ifosfamide and 70% (83/118) receiving other drugs had less than 3 emetic episodes (vomit or retch) during their worst 24 hours of chemotherapy. The number of days without vomiting or retching during and shortly after receiving chemotherapy was also related to the emetic potential of the agents in the regimen: cisplatin 82/182 (45%), ifosfamide 137/213 (64%) and other agents 430/566 (76%). The control of nausea appeared better than that of emesis in each of the sub-groups analysed. Ondansetron was safe, well tolerated and effective in the prevention of vomiting in children receiving a wide variety of chemotherapy regimens.
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PMID:The efficacy and safety of ondansetron in the prophylaxis of cancer-chemotherapy induced nausea and vomiting in children. 842 9

Despite recent advances in control of acute emesis, delayed nausea and vomiting following cisplatin-based chemotherapy remain a significant cause of treatment-related morbidity. Ondansetron, a selective 5HT3 receptor antagonist, is effective in preventing acute emesis in the initial 24-h period following high-dose cisplatin. The efficacy and safety of ondansetron in preventing the delayed emesis syndrome during days 2-5 after cisplatin (> or = 100 mg/m2) were evaluated in a double-blind, placebo-controlled multicentre trial. 50 patients having two or fewer emetic episodes during the first 24 h were randomised to receive ondansetron (16 mg) or placebo orally three times daily beginning 24 h after cisplatin. Rates of complete control of emesis were higher in ondansetron-treated patients during each study day, 59-78%, compared with 39-50% in placebo-treated patients, but the differences were statistically superior only on the third study day (P = 0.009). 40% of patients in the ondansetron treatment arm and 33% treated with placebo had complete control of emesis during the entire 4-day study period (P = 0.648). Withdrawal from study due to nausea and vomiting occurred in 13% of ondansetron-treated patients compared with 33% in the placebo arm (P = 0.102). Control of nausea was better with ondansetron, but differences were not statistically significant. Adverse effects of oral ondansetron given in this dose schedule were minimal. These data suggest that the delayed emesis syndrome may be partially mediated through the 5HT3 receptor, but that a serotonin antagonist alone provides inadequate control. Further investigation of ondansetron-based therapy in this clinical setting is warranted.
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PMID:Delayed emesis following high-dose cisplatin: a double-blind randomised comparative trial of ondansetron (GR 38032F) versus placebo. 842 24

18 consecutive patients with acute myeloid leukaemia (AML) treated with 34 cycles of intensive chemotherapy received ondansetron as antiemetic treatment. 14 patients were chemotherapy-naive, while 4 patients were treated for relapsed leukaemia. All patients received at least one cycle of chemotherapy, 11 patients (61%) received two cycles and 5 patients (28%) received three cycles. The remission induction regimen consisted of cytarabine 200 mg/m2 daily from day 1 to day 7, in combination with an anthracycline or amsacrine on 3 days. During the second and third cycle the dose of cytarabine was increased. Ondansetron was administered as follows: 8 mg intravenously before the start of chemotherapy, followed by 8 mg orally three times daily for 10 days. 50% of patients had no episodes of vomiting during the first cycle of chemotherapy and 78% had less than five episodes of vomiting over 10 days. 72% of patients had no or only mild nausea. These high response rates were maintained during the subsequent cycles. No side-effects due to ondansetron were registered. These data indicate that ondansetron is efficacious in preventing nausea and vomiting in patients with AML treated with intensive chemotherapy.
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PMID:Control of nausea and vomiting with ondansetron in patients treated with intensive non-cisplatin chemotherapy for acute myeloid leukaemia. 843 1

Thirty-one selected patients with various haematological malignancies who received a 10 Gy-4 h total body irradiation (TBI) at the Institut Gustave Roussy 24 h before high dose cyclophosphamide for bone marrow transplantation, were prospectively evaluated for gastrointestinal symptoms, body temperature, consciousness, headache, xerostomia, parotiditis, ocular symptoms, blood pressure, and respiratory and cutaneous signs for 24 h. In spite of prophylactic administration of various anti-emetic agents, 90% of the patients experienced nausea and 80% experienced vomiting. An almost constant body temperature peak--up to 40.8 degrees C--was registered 6 h after the start of irradiation. No drowsiness was reported since the introduction of the new anti-emetic agent Ondansetron. Nearly half the patients (42%) complained of headache. The proportion of patients experiencing early (during TBI) xerostomia was 61%. 74% of patients complained of parotiditis in the first 24 h. Although this low dose rate whole body irradiation is not likely to be exactly replicated in many accidental human exposures, the incidence rate and the time-course of the observed prodromal phase symptoms may prove helpful for early triage in the case of accidental irradiation.
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PMID:Prospective study of the clinical symptoms of therapeutic whole body irradiation. 844 18

This randomised, double-blind, parallel-group study was carried out to compare the efficacy and safety profile of ondansetron plus dexamethasone and metoclopramide plus dexamethasone in patients receiving fractionated cisplatin (20-25 mg/m2/day) chemotherapy for the treatment of testicular cancer. An interim analysis of 95 patients showed that the ondansetron regimen was significantly superior compared to the metoclopramide regimen (p < 0.001). According to the study protocol the study was terminated at this stage. At the time the decision to stop the study was taken, a total of 113 patients had been enrolled and were evaluable on an 'intention to treat' basis. Fifty-six of these had received ondansetron (32 mg i.v. single dose/day) plus dexamethasone (20 mg i.v. single dose/day) and 57 were given metoclopramide (2 mg/kg or 1 mg/kg i.v. twice a day) plus dexamethasone (20 mg i.v. single dose/day). The ondansetron regimen was significantly superior in the control of emesis and nausea. Seventy-one percent of patients experienced 2 or fewer emetic episodes over the entire 5-day study period compared with 26% of patients given metoclopramide (p < 0.001). Seventy-nine percent of patients in the ondansetron group experienced 'none' or only 'mild' nausea compared with 39% of patients in the metoclopramide group (p < 0.001). The dose of metoclopramide had to be reduced during the study from 2 mg/kg i.v. twice daily to 1 mg/kg i.v. twice daily because 4 of the first 8 patients randomised to this treatment experienced extrapyramidal reactions. Ondansetron was well tolerated and it did not induce any extrapyramidal reactions. The results of this study show that ondansetron plus dexamethasone represents a very effective treatment option for patients receiving fractionated cisplatin chemotherapy for testicular cancer.
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PMID:Role of ondansetron plus dexamethasone in fractionated chemotherapy. 845 87

This paper describes a multicentre, double-blind, parallel group study which compared ondansetron (0.15 mg/kg i.v. x 3) plus dexamethasone (20 mg i.v.) with metoclopramide (3 mg/kg i.v. x 2) plus dexamethasone (20 mg i.v.) and diphenhydramine (50 mg i.v.) for the prevention of cisplatin-induced emesis and nausea. Two hundred and eighty-nine consecutive patients receiving chemotherapy containing cisplatin at doses > or = 50 mg/m2 entered the study and 267 patients were evaluable for efficacy. The ondansetron regimen was significantly superior compared with the metoclopramide regimen in the control of acute emesis and nausea. Ondansetron plus dexamethasone provided complete protection against retching and vomiting in 79% of patients compared with 59% of patients given the metoclopramide combination (p < 0.002). Similarly ondansetron plus dexamethasone completely prevented nausea in 77% of patients, whereas the metoclopramide combination protected 66% of patients (p < 0.051). Success (no nausea and no emesis) was afforded to 69% of those patients given ondansetron plus dexamethasone as opposed to 50% of patients given the metoclopramide combination (p < 0.003). From day 2-4 all patients received the same anti-emetic regimen of oral metoclopramide and intramuscular dexamethasone. Significantly fewer patients who had received the ondansetron regimen on day 1 vomited on days 2 and 3 compared with those who had received the triple drug combination (84-86 and 68-71%, respectively, p < 0.006). Nausea was also better controlled in this group on day 2. On subsequent cisplatin cycles, the incidence of acute vomiting rose to 53% in those patients given the metoclopramide regimen, but remained low (26%) in the group treated with ondansetron plus dexamethasone. Patients receiving the metoclopramide regimen had significantly more sedation than patients receiving ondansetron plus dexamethasone (12 vs. 2%; p < 0.005). Extrapyramidal reactions were only observed in metoclopramide-treated patients (3%). The results of this study suggest that ondansetron plus dexamethasone is a more effective and better tolerated anti-emetic regimen compared with metoclopramide plus dexamethasone and diphenhydramine for the prevention of acute cisplatin-induced emesis.
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PMID:Ondansetron plus dexamethasone compared to the 'standard' metoclopramide combination. 845 86

Ondansetron and droperidol are both effective prophylactic antiemetics for gynecologic outpatient procedures. However, increased drowsiness, delayed discharge, and postdischarge restlessness may occur with droperidol, and ondansetron is costly. In this prospective, randomized, double-blind, placebo-controlled study involving 161 women, we compared the efficacy, safety, and cost-effectiveness of ondansetron (4 mg intravenously [i.v.] with droperidol (0.65 mg or 1.25 mg i.v.) in the prevention of postoperative nausea and vomiting (PONV) after outpatient gynecologic surgery. The incidence of PONV, times to achieving preset recovery criteria, and patient-evaluated visual analog scales for sedation, anxiety, pain, and nausea were recorded, along with postdischarge emetic episodes, medications, quality of sleep, and time to resumption of food intake, normal activity, and return to work. A decision analysis tree was used to divide each data set into nine mutually exclusive subgroups, and costs and probabilities were assigned to each subgroup. The cost-effectiveness ratio was determined by summing these weighted costs and dividing by the number of patients free from both PONV and side effects of antiemetic therapy. The incidence of PONV in the hospital and after discharge, the need for rescue antiemetic therapy, and recovery and discharge times were similar for the ondansetron and both droperidol groups but differed significantly from those for the placebo group. The cost-effectiveness ratios for both droperidol 0.65 mg and 1.25 mg groups were significantly lower than those for the ondansetron and placebo groups. We conclude that droperidol 0.625 mg i.v. provides antiemetic prophylaxis comparable to that of ondansetron 4 mg i.v. without increasing side effects or delaying discharge and is most cost-effective.
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PMID:A comparison of costs and efficacy of ondansetron and droperidol as prophylactic antiemetic therapy for elective outpatient gynecologic procedures. 1032 Feb 2

Ten children receiving 5 to 6 week courses of radiotherapy after brain tumor surgery were given ondansetron treatment for persistent nausea and emesis. All patients continued the ondansetron treatment until the end of their radiotherapy course. Nausea, emesis, appetite, and adverse events were scored throughout the ondansetron treatment period. Ondansetron was well tolerated by all patients and was effective at reducing symptoms in 60% of the children.
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PMID:Ondansetron in radiation therapy of brain tumor in children. 873 40

The new antiemetic ondansetron is effective for the prophylaxis and treatment of postoperative nausea and vomiting (PONV), but has been subject to limited comparative evaluation in surgical inpatients. Two hundred and seventy women having abdominal gynaecological surgery were investigated for 24 hours postoperatively in a randomized, double-blind, placebo-controlled study of intraoperative intravenous ondansetron 8 mg (n = 83), droperidol 2.5 mg (n = 89) or saline placebo (n = 87). Patients receiving either ondansetron or droperidol remained likely to vomit, although the incidence was significantly reduced compared with placebo (72% and 83% versus 91%, P < 0.01). Both drugs also resulted in significantly fewer vomiting episodes (P < 0.001), lower nausea scores (P < 0.05) and a lower incidence of patients requiring treatment for PONV (P < 0.01). Compared with droperidol, the risk of vomiting after ondansetron was less (odds ratio 0.5, CI 0.3-1.0). Ondansetron resulted in fewer vomiting episodes (P < 0.05) and a higher percentage of patients free of nausea after six hours postoperatively (P < 0.05). In patients with a past history of PONV, both drugs had a similar short-lived antiemetic effect, reducing the incidence of vomiting and the need for treatment while in the recovery room, but not thereafter. Droperidol was associated with significantly less headache (P < 0.05), but higher early sedation scores (P < 0.05). Although, compared to placebo, both droperidol and ondansetron administered intraoperatively reduced vomiting after major abdominal gynaecological surgery, the incidence during the first 24 postoperative hours was very high in all groups. Ondansetron reduced the risk of experiencing nausea after six hours postoperatively and the risk of vomiting, with respect to the total number of episodes, in the first 24 hours. It was no better than droperidol, however, in reducing the incidence of vomiting or the need for antiemetic treatment during the first postoperative day, whether or not patients had a past history of PONV. It was no better than droperidol, however, in reducing the incidence of vomiting or the need for antiemetic treatment during the first postoperative day, whether or not patients had a past history of PONV.
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PMID:Single-dose prophylaxis for postoperative nausea and vomiting after major abdominal surgery: ondansetron versus droperidol. 878 52

The efficacy of ondansetron 4 mg was compared with metoclopramide 10 mg for the prevention of post-operative nausea and vomiting in patients after major gynaecological abdominal surgery. Anaesthesia was standardized using thiopentone, atracurium and methadone for induction followed by isoflurane in nitrous oxide-oxygen mixture. Fifty patients were randomized in a double-blind fashion to either receive intravenous (i.v.) ondansetron 4 mg or metoclopramide 10 mg during closure of the pelvic peritoneum. The incidence and frequency of vomiting, and the incidence of severe nausea was recorded for 24 h after surgery. One patient was excluded because of respiratory depression. In the first 4 h after surgery, five patients (20%) in the ondansetron group (n = 25) and eight patients (33%) in the metoclopramide group (n = 24) vomited, whereas at 4-12 h, this increased to 11 patients (44%) and nine patients (37.5%) respectively. The incidence was 52 and 37.5% respectively in the subsequent 12-24 h. The highest incidence of nausea was in the first 4 h after surgery, being 56 and 37.5% in the ondansetron and the metoclopramide groups respectively. This decreased to less than 25% in both groups in the 12-24 h period. Ondansetron 4 mg and metoclopramide 10 mg had similar but short lasting efficacy for the prevention of vomiting in patients who received continued opioid analgesia after major gynaecological surgery.
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PMID:Comparison of ondansetron and metoclopramide for the prevention of post-operative nausea and vomiting after major gynaecological surgery. 888 24


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