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Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy.

It is commonly claimed that the nausea and vomiting accompanying cytotoxic chemotherapy have a negative impact on health-related quality of life. While this may seem self-evident, until a few years ago there was little empirical data demonstrating that the failure to control postchemotherapy emesis affects aspects of quality of life. In spite of their limitations, several observational studies showed that nausea and vomiting associated with chemotherapy induced a decrease in health-related quality of life with respect to patients without nausea and vomiting. This has also been demonstrated after the adjustment for health-related quality of life before chemotherapy that is an important prognostic factor of chemotherapy-induced nausea and vomiting. Furthermore, one study suggests that the optimal time of assessment of quality of life to evaluate the impact of chemotherapy-induced nausea and vomiting is day 4 if a 3-day recall period is used or day 8 when the recall period is 7 days. In double-blind studies the efficacy, tolerability and impact on quality of life of the 5-HT3 receptor antagonists was superior with respect to metoclopramide, alizapride and prochlorperazine. Similar results have been achieved with the combination of ondansetron with dexamethasone, the standard treatment for the prevention of acute emesis induced by moderately emetogenic chemotherapy, with respect to the metoclopramide plus dexamethasone combination. Instead, in another double-blind study, in patients submitted to moderately emetogenic chemotherapy, a 5-HT3 antagonist did not seem to significantly increase complete protection from delayed emesis and the patients' quality of life with respect to dexamethasone alone. In conclusion, the evaluation of quality of life in randomized trials comparing different antiemetic drugs for the prevention of chemotherapy-induced nausea and vomiting can add important information useful for the choice of the optimal antiemetic treatment.

Antiemetics↗

Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. We compared the impact of acute (during the first 24 hours postchemotherapy) and delayed (days 2 through 5 postchemotherapy) CINV on patients' quality of life (QoL) after highly or moderately emetogenic chemotherapy (HEC and MEC, respectively). PATIENTS AND METHODS: This prospective, multicenter, multinational study was conducted in 14 medical practices on cancer patients undergoing either HEC or MEC treatment. Patients recorded episodes of nausea and vomiting in a diary. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire at baseline and on day 6. RESULTS: A total of 298 patients were assessable (67 HEC patients, 231 MEC patients). Emesis was reported by 36.4% of patients (13.2% acute, 32.5% delayed) and nausea by 59.7% (36.2% acute, 54.3% delayed). HEC patients reported significantly lower mean FLIE total score than MEC patients (95.5 v 107.8 respectively; P = .0049). Among all patients, the nausea score was significantly lower than the vomiting score (50.0 and 55.3, respectively; P = .0097). Of the 173 patients who experienced neither vomiting nor nausea during the first 24 hours postchemotherapy, 22.9% reported an impact of CINV on daily life caused by delayed CINV. CONCLUSION: CINV continues to adversely affect patients' QoL despite antiemetic therapy even after treatment with only moderately emetogenic chemotherapy regimens, and even in the subgroup of patients who do not experience nausea and vomiting during the first 24 hours. On the basis of the FLIE results in this study, nausea had a stronger negative impact on patients' daily lives than vomiting.

Adult↗

Comparison of domperidone, droperidol, and metoclopramide in the prevention and treatment of nausea and vomiting after balanced general anesthesia.

Women (185) undergoing elective orthopedic surgery under balanced general anesthesia were given 5 or 10 mg of domperidone, 1.25 mg of droperidol, 10 mg of metoclopramide, or a saline placebo intravenously in a double-blind random fashion 5 minutes before the end of anesthesia to prevent postoperative vomiting. Administration of the same antiemetic was repeated intramuscularly during the first 24 hours postoperatively if the patient complained of nausea or retched or vomited. Sigificantly (p less than 0.05 to p less than 0.001), fewer of the patients given droperidol were nauseated (25%) or vomited (17%) in comparison with patients given saline (incidence of nausea was 55% and vomiting 40%). Incidences of nausea and vomiting were similar in patients given domperidone, metoclopramide, or saline. Furthermore, 39 to 45% of the patients given domperidone, metoclopramide, or saline needed additional doses of the same drug, whereas only 22% of the patient given droperidol required a second dose. It is concluded that droperidol is effective in the prevention and treatment of postoperative nausea and vomiting after balanced general anesthesia but that domperidone or metoclopramide are not.

Adult↗

The twenty-degree reverse-Trendelenburg position decreases the incidence and severity of postoperative nausea and vomiting after thyroid surgery.

BACKGROUND: In this randomized, single-blind, controlled study, we evaluated whether the 20 degrees reverse-Trendelenburg position had an effect on postoperative nausea and vomiting in patients undergoing thyroid surgery. METHODS: Patients (n = 224) were given a standardized propofol anesthetic. Intraoperatively, patients were randomly assigned into two groups according to the tilt of the table maintained during surgery: patients were positioned with the neck extended and the table tilted with 20 degrees reverse-Trendelenburg or with the neck extended and the table positioned at a horizontal tilt. All episodes of postoperative nausea, vomiting, nausea severity score, frequency of vomiting, and the use of antiemetics were recorded during the first 24 h after anesthesia. We divided this time period into 0-3 h and 3-24 h. RESULTS: During the 0-3 h postoperative period, all observed episodes were comparable between groups. However, during the 3-24 h and the overall postoperative period, the incidence of nausea and/or vomiting, the nausea severity score, and frequency of vomiting were significantly less in the 20 degrees reverse-Trendelenburg position. CONCLUSION: The 20 degrees reverse-Trendelenburg position effectively ameliorates postoperative nausea and/or vomiting.

Adult↗

Mirtazapine (Remeron) as treatment for non-mechanical vomiting after gastric bypass.

Two morbidly obese patients are reported who underwent gastric bypass and suffered nausea and vomiting 1 month after the operation. Endoscopy and upper GI series showed no evidence of stomal stenosis or other mechanical cause for a GI obstruction. Control of vomiting by current antiemetic drugs such as bromopride and ondansetrone was unsuccessful. The patients were then given Remeron Soltab (mirtazapine, Organon, Brazil) 30 mg once per day orally for 2 to 8 months. Nausea and vomiting disappeared within days after beginning the medication. Stomal stenosis is the main cause of vomiting after gastric bypass. After ruling out mechanical causes, other reasons for postoperative vomiting must be considered. Mirtazapine is a noradrenergic and specific serotonergic antidepressant, which blocks the 5HT3 receptor, leading to an antiemetic effect. It has successfully been used as an antiemetic drug in patients undergoing chemotherapy. We concluded that mirtazapine may be a successful option to treat non-mechanical postoperative vomiting in morbidly obese patients after gastric bypass.

Adrenergic alpha-Antagonists↗

Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control.

Nausea and vomiting are two of the most feared side effects of cancer chemotherapy and radiotherapy. Chemotherapy-induced nausea and vomiting can be broadly categorized as acute (occurring within 24 hours of therapy), delayed (persisting for 6-7 days after therapy), or anticipatory (occurring prior to chemotherapy administration). Breakthrough and refractory nausea and vomiting describe the symptoms of uncontrolled emesis. Evidence suggests that good control of nausea and vomiting during the acute period correlates with the control of delayed emesis. Conversely, protection failure during the first 24 hours has a high predictive value for delayed emesis in the same cycle. The 5-HT(3)-receptor antagonists, regarded as the 'gold standard' in antiemetic therapy, are the first-line treatment for moderately and highly emetogenic chemotherapy and radiotherapy regimens in adults and children. Evidence suggests that the 5-HT(3)-receptor antagonists administered in combination with corticosteroids afford the best protection from symptoms of acute emesis and, by extrapolation, the most effective prevention of delayed emesis. Antiemetic therapeutic guidelines stress that the goal of therapy is to prevent cytostatic-induced nausea and vomiting. Therefore, the prophylactic use of the most effective antiemetic regimen-taking into consideration the emetogenicity of the chemotherapy and individual patient characteristics-must be adhered to in order to prevent acute, delayed, and anticipatory nausea and vomiting.

Antiemetics↗

Ondansetron. An update of its therapeutic use in chemotherapy-induced and postoperative nausea and vomiting.

Ondansetron is a selective 5-HT3 receptor antagonist which has previously been reported in the Journal to be a promising new agent for use as prophylaxis against nausea and vomiting caused by chemotherapy and radiotherapy. Since the publication of this original review, further studies have been published that show ondansetron to be an effective antiemetic agent in patients receiving chemotherapy and radiotherapy. Several studies have shown ondansetron to be a more effective antiemetic agent than high-dose metoclopramide in patients with emesis induced by high- and low-dose cisplatin treatment, and noncisplatin chemotherapy-induced emesis. The drug as mono-therapy does not appear to offer any advantage over alternative therapies against delayed high-dose cisplatin-induced nausea and vomiting; however, extremely limited data suggest that ondansetron plus dexamethasone may be useful in this indication. Trials have shown combination therapy with ondansetron and dexamethasone to be significantly more effective than both ondansetron monotherapy and a standard antiemetic regimen comprising metoclopramide, dexamethasone and diphenhydramine against acute high-dose cisplatin-induced emesis. Results from a number of small scale trials suggest that ondansetron may be an effective treatment for chemotherapy-induced emesis refractory to conventional antiemetic therapy. Ondansetron also appears to be more effective against refractory emesis induced by noncisplatin chemotherapy than that induced by cisplatin chemotherapy. Several trials have shown ondansetron to be more effective than placebo as prophylaxis against postoperative nausea and vomiting; a further trial has shown single-dose ondansetron to be significantly more effective than single-dose droperidol or metoclopramide in this indication. In addition, several trials have shown ondansetron to be more effective than placebo as treatment for nausea and vomiting that has commenced postoperatively. The overall incidence of adverse events in ondansetron recipients during chemotherapy-induced emesis studies was 36%. Headache and constipation are the most common adverse events during ondansetron therapy. Thus, recent data affirms the efficacy of ondansetron in the treatment of acute chemotherapy-induced nausea and vomiting and shows it to be especially efficacious when combined with dexamethasone. It appears that the drug will also have a substantial role in the prophylaxis and treatment of postoperative nausea and vomiting.

Antineoplastic Agents↗

Prevention of postoperative nausea and vomiting after thyroidectomy: combined antiemetic treatment with dexamethasone and ginger versus dexamethasone alone.

BACKGROUND: The aim of this study was to compare the prophylactic effects of dexamethasone plus ginger and dexamethasone alone on postoperative nausea and vomiting (PONV) in patients undergoing thyroidectomy. METHODS: One hundred and twenty patients undergoing general anaesthesia for thyroidectomy were enrolled in this randomised, double-blind study. Patients received oral diazepam 10mg with either oral placebo (group I) or 0.5g of ginger (group II) as premedication 1 hour prior to surgery. Standard general anaesthetic techniques and postoperative analgesia were employed. Both group I and group II received intravenous dexamethasone 150 microg/kg immediately before the induction of anaesthesia. Data were recorded over a 24-hour observation period after surgery. RESULTS: In the dexamethasone-treated group, 14 patients experienced nausea, two patients retched, three patients vomited once, two patients vomited repeatedly, and 14 patients required a rescue antiemetic. In the dexamethasone-plus-ginger-treated group, 12 patients experienced nausea, one patient retched, four patients vomited once, no patients vomited repeatedly, and 13 patients required a rescue antiemetic. Dexamethasone plus ginger did not significantly reduce nausea and vomiting compared with dexamethasone alone during the observation period. CONCLUSION: In conclusion, the prophylactic combination of antiemetic treatment with dexamethasone and ginger was not clinically or statistically superior to dexamethasone alone in preventing PONV in patients undergoing thyroidectomy.

Administration, Oral↗

[Olanzapine use in cancer patients for refractory vomiting].

Recent investigations suggest the efficacy of olanzapine in cancer patients with intractable vomiting or chemotherapy-induced nausea. Olanzapine,indicated for schizophrenia in Japan, has an affinity for multiple neurotransmitter receptors including dopaminergic, serotonergic, histaminergic, adrenergic and muscarinic receptors. This pharmacological activity thus has a potential role in the treatment of nausea and vomiting. In the present study, olanzapine was given to five cancer patients with refractory vomiting to standard medications. In 3 cases, olanzapine resolved vomiting completely and also improved anorexia, In 2 cases, vomiting was controlled for a limited period. No adverse effect was observed. These results suggest olanzapine is a useful agent for the management of both vomiting and anorexia.

Aged↗

Characteristics of vomiting associated with acute sustained release theophylline poisoning: implications for management with oral activated charcoal.

Vomiting in acute theophylline toxicity has assumed increased clinical importance since the introduction of multiple dose activated charcoal therapy. We performed a prospective study of 26 patients with acute overdose of sustained release theophylline to characterize vomiting, and its possible interference with the acceptance of activated charcoal. Twenty five of 26 patients vomited. The duration of vomiting correlated with both peak serum theophylline concentrations (p less than 0.001) and the duration of theophylline toxicity (p less than 0.001). Vomiting extended over 63% of the drug's absorptive phase (the time interval between ingestion and the peak level) and 49% of the elimination phase (the time interval between the peak level and decrease of theophylline level to less than 20 mcg/ml). Patients with peak serum theophylline concentrations less than 70 mcg/ml were able to accept larger amounts of activated charcoal than patients with serum theophylline concentrations greater than 70 mcg/ml (113 +/- 15 gms vs. 57 +/- 24 gms, p less than 0.05). Vomiting in acute sustained release theophylline toxicity is protracted, and limits the use of activated charcoal especially in patients with severe acute theophylline poisoning.

Adult↗

Value of mink vomit model in study of anti-emetic drugs.

AIM: To establish a new, reliable vomit model of minks. METHODS: Adult male minks were randomly divided into 8 groups (n=6): cisplatin (7.5 mg/kg) intraperitoneal injection (i.p.) group, copper sulfate (40 mg/kg) intragastric injection (i.g.) group, apomorphine (1.6 mg/kg) subcutaneous injection (s.c.) group, and 18 Gy whole-body X-irradiation group, ondansetron injection group (2 mg/kg i.p.) 30 min later followed by cisplatin (7.5 mg/kg) i.p., normal saline (NS) i.p. injection control group, metoclopramide injection group (4 mg/kg i.p.) 30 min later followed by apomorphine (1.6 mg/kg) s.c., NS i.g. control group. The frequency of retching and vomiting was calculated. After behavioral experiment, distribution of 5-HT in the ileum was detected by immunohistologic method. RESULTS: Cisplatin, apomorphine, copper sulfate and X-irradiation administered to minks evoked a profound emetic response in the animals. However, retching and vomiting were significantly inhibited by pretreatment with ondansetron and metoclopramide in cisplatin and copper sulfate groups (P=0.018). Immunohistologic result showed that 5-HT released from enterochromaffin cells (EC cells) was involved in vomiting mechanism. CONCLUSION: Mink vomit model has a great value in studying the vomiting mechanism and screening new antiemetic drugs.

Animals↗

Postoperative analgesia and vomiting, with special reference to day-case surgery: a systematic review.

BACKGROUND: Day-case surgery is of great value to patients and the health service. It enables many more patients to be treated properly, and faster than before. Newer, less invasive, operative techniques will allow many more procedures to be carried out. There are many elements to successful day-case surgery. Two key components are the effectiveness of the control of pain after the operation, and the effectiveness of measures to minimise postoperative nausea and vomiting. OBJECTIVES: To enable those caring for patients undergoing day-case surgery to make the best choices for their patients and the health service, this review sought the highest quality evidence on: (1) the effectiveness of the control of pain after an operation; (2) the effectiveness of measures to minimise postoperative nausea and vomiting. METHODS: Full details of the search strategy are presented in the report. RESULTS - ANALGESIA: The systematic reviews of the literature explored whether different interventions work and, if they do work, how well they work. A number of conclusions can be drawn. RESULTS-ANALGESIA, INEFFECTIVE INTERVENTIONS: There is good evidence that some interventions are ineffective. They include: (1) transcutaneous electrical nerve stimulation in acute postoperative pain; (2) the use of local injections of opioids at sites other than the knee joint; (3) the use of dihydrocodeine, 30 mg, in acute postoperative pain (it is no better than placebo). RESULTS-ANALGESIA, INTERVENTIONS OF DOUBTFUL VALUE: Some interventions may be effective but the size of the effect or the complication of undertaking them confers no measurable benefit over conventional methods. Such interventions include: (1) injecting morphine into the knee joint after surgery: there is a small analgesic benefit which may last for up to 24 hours but there is no clear evidence that the size of the benefit is of any clinical value; (2) manoeuvres to try and anticipate pain by using pre-emptive analgesia; these are no more effective than standard methods; (3) administering non-steroidal anti-inflammatory drugs (NSAIDs) by injection or per rectum in patients who can swallow; this appears to be no more effective than giving NSAIDs by mouth and, indeed, may do more harm than good; (4) administering codeine in single doses; this has poor analgesic efficacy. RESULTS-ANALGESIA, INTERVENTIONS OF PROVEN VALUE: These include a number of oral analgesics including (at standard doses): (1) dextropropoxyphene; (2) tramadol; (3) paracetamol; (4) ibuprofen; (5) diclofenac. Diclofenac and ibuprofen at standard doses give analgesia equivalent to that obtained with 10 mg of intramuscular morphine. Each will provide at least 50% pain relief from a single oral dose in patients with moderate or severe postoperative pain. Paracetamol and codeine combinations also appear to be highly effective, although there is little information on the standard doses used in the UK. The relative effectiveness of these analgesics is compared in an effectiveness 'ladder' which can inform prescribers making choices for individual patients, or planning day-case surgery. Dose-response relationships show that higher doses of ibuprofen may be particularly effective. Topical NSAIDs (applied to the skin) are effective in minor injuries and chronic pain but there is no obvious role for them in day-case surgery. RESULTS-POSTOPERATIVE NAUSEA AND VOMITING: The proportion of patients who may feel nauseated or vomit after surgery is very variable, despite similar operations and anaesthetic techniques. Systematic review can still lead to clear estimations of effectiveness of interventions. Whichever anti-emetic is used, the choice is often between prophylactic use (trying to prevent anyone vomiting) and treating those people who do feel nauseated or who may vomit. Systematic reviews of a number of different anti-emetics show clearly that none of the anti-emetics is sufficiently effective to be used for prophylaxis. (ABSTRACT TRUNCATE

Acetaminophen↗

[Usefulness of ramosetron hydrochloride on nausea and vomiting in CMF or CEF therapy for breast cancer].

The inhibitory effect of ramosetron hydrochloride (Ram), a 5-HT3 receptor antagonist, on nausea and vomiting occurring in CMF or CEF therapy as a pre- or postoperative adjuvant chemotherapy or chemotherapy for recurrent cancer was evaluated in 34 patients with breast cancer. On days 1 and 8, the patients received Ram (0.3 mg) concomitantly with these agents intravenously and were observed for nausea and vomiting to evaluate the inhibitory effect. Food intake was observed at the same time. On day 1, there was moderate to severe nausea in one patient and vomiting in two patients, while results for 32 of 34 patients (94.1%) were classified as "excellent". On day 8, no moderate or severe nausea was seen, but vomiting occurred in one patient; the results of 33 patients (97.1%) were classified as "excellent". Even when considering only 12 patients who had experienced nausea or vomiting on chemotherapy, 11 showed an "excellent" response on day 1. Moreover, no patient received any additional dose of an anti-emetic drug within 24 hours of Ram administration. Food intake decreased to less than 50% of the baseline in three patients on day 1 and four patients on day 8. Administration of Ram to breast cancer patients on CMF or CEF therapy is thus concluded to be useful in the inhibition of nausea and vomiting.

Adult↗

Central mechanisms of vomiting.

Nausea and vomiting (emesis) occur under a variety of conditions in response to activation of one or more emetic triggers. The act of vomiting is coordinated by neuronal circuitry located in the brain stem between the obex and the retrofacial nucleus, including the region extending from the nucleus of the solitary tract through the lateral tegmental field of the reticular formation to the ventrolateral medulla. The area postrema, medullary midline, and certain higher brain centers are also important for vomiting. The sensation of nausea is thought to involve the cerebral cortex. The most effective near-term treatment for combating nausea and vomiting associated with cyclic vomiting syndrome may come from experimental drugs (NK-1 receptor antagonists, 5-HT1A receptor agonists) or P6 acustimulation, which have been shown to combat nausea and vomiting in response to a broad spectrum of emetic challenges and thus presumably act on central emetic mechanisms.

Acupuncture Points↗

[Clinical usefulness of ondansetron hydrochloride for nausea and vomiting during repeated courses of chemotherapy for malignant lymphoma--impact of prognosis announcement on anti-emetic effect and evaluation of patient perception of chemotherapy-associated adverse events].

We evaluated the efficacy and safety of ondansetron hydrochloride (OND) on nausea and vomiting during repeated courses of CHOP or ACOMP-B therapy in patients with malignant lymphoma. The impact of the prognosis announcement on the anti-emetic effect and chemotherapy-associated adverse events was also investigated. Forty-two subjects with malignant lymphoma who underwent CHOP or ACOMP-B therapy including cyclophosphamide 600 mg/m2 and adriamycin 40 mg/m2 were investigated for a maximum of 6 courses. For acute nausea and vomiting, ondansetron was injected intravenously before the start of chemotherapy on the first day of each course of chemotherapy. For delayed emesis, ondansetron was administered orally for 4 days from the following day. The efficacy on acute nausea and vomiting was found to be 95.0% (1st course), 95.0% (2nd course), 90.9% (3rd course), 88.2% (4th course), 92.3% (5th course) and 91.7% (6th course), respectively. A high efficacy of > or = 85% was also obtained for delayed nausea and vomiting on each day. Though the adverse event of elevated GPT value developed in one subject. It was mild and resolved. No difference in efficacy was seen with or without announcement of prognosis to patients. Following the investigation on antiemetic effect, patient perception of chemotherapy-induced adverse events was evaluated. The most common event was hair loss, followed by taste abnormality and numbness and hyposthesia of the tips of the fingers. The incidence of nausea and vomiting was the 4th and 5th most common, which are less frequent than in the report of Coates in 1983. In conclusion, ondansetron is considered clinically useful with stable anti-emetic effect on both acute and delayed nausea and vomiting over repeated courses of chemotherapy, without any significant safety problem.

Aged↗

Lack of relationship between infection by Helicobacter pylori and vomiting that usually occurs during pregnancy, although possible relationship with severe forms of emesis.

OBJECTIVE: It has been reported that infection by Helicobacter pylori may cause severe vomiting during pregnancy (hyperemesis gravidarum). Two studies were carried out in order to examine the relationship between this infection and less severe vomiting. DESIGN AND METHODS: The first study was a retrospective study involving 3438 women who required admission to the hospital during pregnancy. In 178 women, vomiting was recorded as one of the diagnoses at the time of discharge. In 162 of these women, a serum specimen was available to study the presence of anti-Helicobacter pylori antibodies (anti-HP Ab). The second study examined the presence of vomiting and anti-HP Ab in an additional 250 pregnant women who were admitted to the Maternity Ward for childbirth. In this study, the duration and intensity of emesis during the previous months was recorded. RESULTS: In the first study, no significant difference was found between the prevalence of anti-HP Ab in the 162 women in the study and a control group of women without emesis (43.2 vs 42.9%, p = NS). In the second study, there was no significant difference in seroprevalence between the women with emesis and the control group without vomiting, with the exception of the more severe cases (anti-HP Ab 77.8%, p < 0.05). CONCLUSION: The results of this study do not show that there is a relationship between infection by Helicobacter pylori and less severe vomiting during pregnancy. Nevertheless, we believe that additional studies should carried out in order to determine the relationship between the more severe cases of emesis during pregnancy and this treatable infection.

Adult↗

Ondansetron antiemetic therapy for chemotherapy and radiotherapy induced vomiting in children.

AIM: To evaluate ondansetron as the sole antiemetic in children treated with emetogenic chemotherapy and irradiation. METHODS: Fifteen children aged 3-11 years were studied. Seven had acute lymphoblastic leukaemia, two acute myeloid leukaemia, two lymphoma and four had other tumours. Ondansetron 5 mg/m2 IV or 4 mg by mouth was given immediately before chemotherapy or radiation treatment and continued eight hourly for 24 hours. Nausea and vomiting was assessed during treatment and for the next 48 hours, and graded using WHO criteria. RESULTS: Thirty-eight courses of chemotherapy were assessed, 27 severely emetogenic and 11 moderately emetogenic. Two included total body irradiation. The most severe nausea and vomiting was grade 2 (transient vomiting) reported in six children. Nausea and vomiting was abolished on subsequent courses in four of these children by increasing the ondansetron dose frequency to six hourly. The remaining children experienced no nausea or vomiting (n = 7) or only nausea (n = 2). Nausea and vomiting were each completely controlled in 27 courses. CONCLUSIONS: Ondansetron is a cost effective and safe antiemetic in children receiving chemotherapy and total body irradiation, minimises weight loss on treatment and enables outpatient chemotherapy in some cases.

Child↗

Phase II trial of ramosetron plus dexamethasone in the prevention of cisplatin-induced nausea and vomiting.

OBJECTIVE: To evaluate the clinical efficacy of ramosetron hydrochloride in the combination with dexamethasone for the prevention of nausea and vomiting induced by cisplatin. MATERIAL AND METHOD: Thirty in-patients with malignant tumor being treated with cisplatin at a dose of 70 mg/m2 or more for a total of 94 cycles were scheduled to receive ramosetron 0. 3 mg IV given 30 minutes before chemotherapy and dexamthasone 20 mg IV on day 1 for the prevention of acute emesis and continued with ramosetron tablet 0.1 mg one tablet orally one hour before chemotherapy or in the morning in case of no chemotherapy scheduled and dexamethasone capsule 5 mg 2 capsules twice daily on day 2 to day 5 for the prevention of delayed emesis. The evaluation period started concomitantly with the start of chemotherapy (hour 0) and continued until 24 hours after completion of chemotherapy. The antiemetic efficacy of ramosetron plus dexamethasone was analyzed according to the occurrence of nausea and vomiting within 24 hours of treatment cycle. The study emphasized both on acute and delayed emesis control. ASSESSMENT: The degree of severity of nausea was determined according to the following criteria: 0: None: nausea does not occur, 1: Mild: slight nausea but no disruption to daily acitivites, 2: Moderate: nausea and some disruption to daily activities, 3: Severe: extreme nausea and severe disruption to daily activities. The control of vomiting episodes was determined according to the frequency of vomiting (including retching) as the following criteria: Complete: 0 emesis episode, Major: 1-2 emesis episodes, Minor: 3-5 emesis episodes, Failure: > 5 emesis episodes. RESULTS: The result of all 94 cycles of the first day of treatment on acute emesis (0-24 hours) were none 80.9%, mild 18.1%, and moderate 1.1% for nausea episode. For the vomiting control were complete 81.9%, major 16%, minor 1.1% and failure 1.1% respectively. The efficacy of the prevention of delayed emesis (day 2 to day 5) for nausea episode were 67%, 66%, 70.2%, and 75.5% no nausea respectively. For the vomiting control were 75.5%, 74.5%, 86.2%, and 88.3% complete control on day 2 to day 5. No serious adverse events occurred. Hiccups, constipation, and dull headache were reported as the common side effects of ramosetron. CONCLUSION: Ramosetron combined with dexamethasone is effective for the prevention of both acute and delayed emesis associated with cisplatin. The prevention of acute emesis seems to be more effective than the prevention of delayed emesis. Adverse events were mild. No serious side effects occurred in the present study.

Adult↗