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Granisetron and ondansetron for chemotherapy-related nausea and vomiting.

The efficacy of granisetron and ondansetron, two serotonin antagonists, as antiemetic agents was studied and compared in the first 24 h follow, by chemotherapy administration. Sixty cancer patients took part in this randomized prospective study. The patients were categorized according to the chemotherapy which was administered. Patients in group A received combinations including the highly emetogenic agents, cisplatinum or adriamycin, patients in group B received regimens which included neither of these agents. Both serotonin antagonists were highly effective, only 9 (16%) out of 58 patients suffered from vomiting, 7 (25%) of the patients on ondansetron and 2 (7%) on granisetron. Splitting the patients into both groups supported the above results. In group A (adriamycin-cisplatinum) only 7 patients (22%) reported vomiting, 5 (33%) on ondansetron vs 2 (12%) on granisetron. In group B, only 2 patients (8%) suffered from vomiting, both patients (15%) on ondansetron while no vomiting was seen in the granisetron patients. Similar results were obtained in preventing nausea in these patients. We conclude that both serotonin antagonists are effective in preventing nausea and vomiting in patients receiving chemotherapy. In all groups tested this study granisetron appeared to be superior, although, this difference failed to reach statistical significance due to the small number of patients analyzed. However, there was no difference in cost effectiveness between the regimens.

Antiemetics↗

Effect of BL-10 (tianzhu), BL-11 (dazhu) and GB-34 (yanglinquan) acuplaster for prevention of vomiting after strabismus surgery in children.

BACKGROUND: Stimulation of P6 (Neiguan) acupoint can prevent nausea and vomiting in adults. However, there is no antiemetic effect in children undergoing strabismus surgery. The effect of P6 may act only on hollow organs; in contrast, BL-10 (Tianzhu), BL-11 (Dazhu) and GB-34 (Yanglinquan) are more related to the meridians of the eye. Therefore these three more relevant acupoints, BL-10, BL-11 and GB-34 were stimulated to evaluate the antiemetic effect in children undergoing strabismus surgery. METHODS: Sixty-five children, ASA physical status I, between 3 and 14 years of age, were randomly divided into two groups as follows: placebo group (n = 31) and acuplaster group (n = 34). Bilateral acupressure using the Vital Point Needleless Acuplaster (Koa, Japan) was applied to BL-10, BL-11 and GB-34 points the night before surgery. Anesthesia was induced and maintained with halothane and nitrous oxide in oxygen. Postoperative emesis was assessed at early (at PACU) and late (at ward) phases, and was recorded by an investigator blind to the treatment characteristics. RESULTS: In the early emesis phase, the incidence of vomiting was 35.5% for placebo group, compared with 14.7% for acuplaster group. In the late emesis phase, acuplaster patients had a significantly lower incidence of vomiting (23.5% vs. 58.1% in placebo patients, p < 0.05). The overall postoperative vomiting incidence in the acuplaster patients in a 24 h period which was significantly decreased was 29.4% as opposed 64.5% in the placebo group (p < 0.05). CONCLUSIONS: The results demonstrated that prophylactic use of bilateral noninvasive acuplaster on the BL-10, BL-11, and GB-34 acupoints significantly reduces vomiting after strabismus correction. The mechanism may be dispersal of these three acupoints, thus diminishing the parasympathetic stimulation resulting from surgical traction of eye muscles.

Acupressure↗

[Effect of ondansetron hydrochloride injection and tablet against nausea and vomiting in lung cancer patients receiving carboplatin].

We investigated the efficacy of combination of ondansetron hydrochloride injection and tablet against nausea and vomiting in 22 lung cancer patients (total number of chemotherapy courses: 23) receiving chemotherapy of single-dose carboplatin (CBDCA) at a dose of 302.2 +/- 31.9 mg/m2. For suppressing emesis, the patients were given 4 mg of ondansetron injection on the day of CBDCA injection (Day 1), and 4 mg/day of ondansetron tablet for Days 2 to 5. The following results were obtained 5 days after the administration of carboplatin. 1) Control of nausea graded 'Good' or better counted for 95% or higher of all cases for each day of the chemotherapy. A complete nausea suppression rate was seen in 91.3%, 81.0%, 71.4%, 63.6% and 71.4% from Day 1 to Day 5, respectively. 2) Control of vomiting graded 'Major' control or better was achieved in 95% or more of all cases, for each day. The complete vomiting suppression rate observed from Day 1 to Day 5 was 91.3%, 78.3%, 65.2%, 69.6% and 91.3%, respectively. 3) Inhibitory effect on nausea and vomiting for each day of Days 1 to 5 graded as 'Effective' or better was shown in 90% or higher of all cases; based on overall judgement for Days 1 to 5, all cases were graded as 'Effective' or better. 4) The proportion of cases which was evaluated as 'Can eat most of the meal' was 88.0%, 73.9%, 50.7%, 50.7% and 65.2% from Days 1 to 5, respectively, against 95.7% prior to the start of chemotherapy. 5) No adverse drug reaction or abnormal clinical laboratory values were seen along with ondansetron. 6) In conclusion, combined treatment with ondansetron injection and tablet was considered clinically useful in control of nausea and vomiting during administration of carboplatin, and may also be useful for out-patient chemotherapy.

Adult↗

Vomiting after adenotonsillectomy in children: a comparison of ondansetron, dimenhydrinate, and placebo.

UNLABELLED: We compared the effectiveness of ondansetron, dimenhydrinate, and placebo for the prevention of postoperative vomiting in children after adenotonsillectomy. In a randomized, placebo-controlled, double-blind study, 74 children, 2-10 yr of age scheduled for adenotonsillectomy as outpatients were given a single i.v. dose of ondansetron (0.1 mg/kg, n = 26), dimenhydrinate (0.5 mg/kg, n = 25), or placebo (saline, n = 23) at induction of anesthesia. The incidence of retching and vomiting (POV) and side effects observed 24 h after surgery were recorded. Demographic data were similar among the three groups. The 24-h incidence of POV was 42%, 79%, and 82% in the ondansetron, dimenhydrinate, and placebo groups, respectively (ondansetron compared with dimenhydrinate [P < 0.02] or placebo [P < 0.01]). The study was stopped after two children vomited large volumes of bloody fluid 9 and 22 h after surgery without previous signs of occult bleeding. Both children had received ondansetron. We conclude that ondansetron is superior to dimenhydrinate or placebo for the prevention of POV after adenotonsillectomy in children. Antiemetics may mask the signs of bleeding after adenotonsillectomy. IMPLICATIONS: I.v. ondansetron (0.1 mg/kg) is more effective than both dimenhydrinate and placebo in preventing vomiting after adenotonsillectomy in healthy children. However, antiemetics may also mask the presence of blood in the stomach by preventing vomiting, and this should be appreciated when adenotonsillectomy is performed on an outpatient basis.

Antiemetics↗

How can we best prevent or treat postoperative nausea and vomiting?

In pursuit of preventing or rapidly rescuing patients from postoperative nausea and vomiting, new clinical studies provide revised postoperative nausea and vomiting risk prediction tools, risk stratification formulae, comparative trials to identify the most appropriate cost-effective anti-emetics, and several trials recommending the addition of steroids in anti-emetic prophylactic multimodal approaches. Common variables that identify high-risk postoperative nausea and vomiting patients include female sex, a history of postoperative nausea and vomiting or motion sickness, young age, volatile anesthetic agents, nitrous oxide, and the administration of opioids. The most successful approach to the prevention of postoperative nausea and vomiting is multimodal, with combination anti-emetics, dexamethasone, aggressive hydration, the avoidance of opioids, and aggressive pain control.

Journal Article↗

Management of postoperative vomiting in pediatric patients.

PURPOSE OF REVIEW: Postoperative vomiting remains a common complication of general anesthesia and occurs more frequently in children than adults. Prophylactic antiemetics have limited efficacy and have a potential for side effects. The new 5 HT3 antagonists are effective but expensive, while the older less expensive drugs such as droperidol have come under disrepute because of the potential for serious, life-threatening, cardiac arrhythmias. This review examines the literature to aid practicing anesthesiologists in the choice of patient who will benefit from prophylactic antiemetics. RECENT FINDINGS: In this review we discuss the factors associated with postoperative vomiting that are and are not under the control of the anesthesiologist. The Consensus Panel recommendations for reducing the risks of postoperative vomiting and for the rational use of prophylactic antiemetics in selected cases are reviewed. The controversy over the 'black box warning' on the use of droperidol is discussed. Finally, the evidence supports the importance of choosing a drug from another class for rescue therapy when prophylaxis with one drug has failed. SUMMARY: Anesthesiologists should practice evidence-based medicine in reducing the common anesthetic complication of postoperative vomiting by an individualized approach that balances the choice of drugs with the expected risk of postoperative vomiting for cost-effective management.

Journal Article↗

Nausea and vomiting of early pregnancy and pregnancy outcome. An epidemiological study.

The association of nausea and vomiting in pregnancy with the outcome of pregnancy was investigated in a historical cohort of 903 women in Los Angeles, California, USA. Multivariable statistical methods were employed to control for the potential confounding effects of age, ethnicity, occupation, and anti-emetic use on pregnancy outcome. The analyses indicated that vomiting was associated with decreased risk of miscarriage (adjusted odds ratio 0.18, 95% CI 0.06 to 0.53); women with nausea but no vomiting had a miscarriage risk equal to that in the sample overall. Among the subsample of women with signs of threatened miscarriage, those who had experienced vomiting had a decreased risk of miscarriage (10.3% vs 31.7% in the subsample). No statistically significant association was observed between nausea and vomiting of pregnancy and other pregnancy outcomes (perinatal mortality, fetal anomalies, neonatal anthropometric measures).

Abortion, Spontaneous↗

Treatment of established postoperative nausea and vomiting: a quantitative systematic review.

BACKGROUND: The relative efficacy of antiemetics for the treatment of postoperative nausea and vomiting (PONV) is poorly understood. METHODS: Systematic search (MEDLINE, Embase, Cochrane Library, bibliographies, any language, to 8.2000) for randomised comparisons of antiemetics with any comparator for the treatment of established PONV. Dichotomous data on prevention of further nausea and vomiting, and on side effects were combined using a fixed effect model. RESULTS: In seven trials (1,267 patients), 11 different antiemetics were tested without placebos; these data were not further analysed. Eighteen trials (3,809) had placebo controls. Dolasetron 12.5-100 mg, granisetron 0.1-3 mg, tropisetron 0.5-5 mg, and ondansetron 1-8 mg prevented further vomiting with little evidence of dose-responsiveness; with all regimens, absolute risk reductions compared with placebo were 20%-30%. The anti-nausea effect was less pronounced. Headache was dose-dependent. Results on propofol were contradictory. The NK1 antagonist GR205171, isopropyl alcohol vapor, metoclopramide, domperidone, and midazolam were tested in one trial each with a limited number of patients. CONCLUSIONS: Of 100 vomiting surgical patients receiving a 5-HT3 receptor antagonist, 20 to 30 will stop vomiting who would not have done so had they received a placebo; less will profit from the anti-nausea effect. There is a lack of evidence for a clinically relevant dose-response; minimal effective doses may be used. There is a discrepancy between the plethora of trials on prevention of PONV and the paucity of trials on treatment of established symptoms. Valid data on the therapeutic efficacy of classic antiemetics, which have been used for decades, are needed.

Journal Article↗

Treating pregnancy-related nausea and vomiting with ginger.

OBJECTIVE: To review literature assessing the safety and efficacy of the use of ginger to treat nausea and vomiting in pregnancy. DATA SOURCES: Iowa Drug Information Service (1966-September 2004), International Pharmaceutical Abstracts (1971-September 2004), MEDLINE (1966-September 2004), and EMBASE (1966-September 2004) were searched. Key terms included ginger, nausea, vomiting, emesis, and pregnancy. DATA SYNTHESIS: Studies evaluating the safety and efficacy of ginger in the management of nausea and vomiting in pregnancy were reviewed. Various doses and forms of ginger were used to treat women during their first and second trimesters of pregnancy. Ginger has been shown to improve the symptoms of nausea and vomiting compared with placebo in pregnant women. CONCLUSIONS: While data are insufficient to recommend ginger universally and there are concerns with product quality due to limited regulation of dietary supplements, ginger appears to be a fairly low-risk and effective treatment for nausea and vomiting associated with pregnancy. In low doses, this may be appropriate for patients not responding to traditional first-line therapies.

Clinical Trials as Topic↗

Relationship between vitamin use, smoking, and nausea and vomiting of pregnancy.

BACKGROUND: Nausea and vomiting in pregnancy (NVP) is a common complaint but risk factors for NVP are not well characterized. METHODS: Occurrence of NVP was studied by questionnaires given to pregnant women at their first visit to the antenatal care unit and were returned around gestational week 28. RESULTS: Analysis of 3675 completed questionnaires was made. Nausea and vomiting in pregnancy was reported by 79% of the women, approximately half of which had been vomiting. Various therapies (drugs, acupuncture, acupressure) were tried by 18% of the women with NVP, of which the majority used drugs, most notably antihistamines (specifically meclozine). Hospitalization occurred in 1% of all women. Nausea and vomiting in pregnancy caused 28% of all sick-leaves during the first 28 weeks of pregnancy. Low maternal age and parity 1+ independently increased the risk for NVP. Smoking before pregnancy and using vitamins in early pregnancy were associated with a decreased risk for NVP. Women working outside the home had a lower rate of NVP than housewives and women out of work. CONCLUSIONS: Nausea and vomiting in pregnancy is a common complaint with a significant impact on leave of absence from work. The study identifies a number of factors that are related to the occurrence of NVP and that may give hints on the etiology of the condition.

Adult↗

[Assessment of thyroid function in women treated for vomiting in early pregnancy].

OBJECTIVES: Hyperthyroidism does not influence procreation ability significantly, but very often causes complications of the course of pregnancy and increases neonatal morbidity and mortality in newborns. Nausea and vomiting in the first trimester of pregnancy are very common complaints in these patients. DESIGN: The aim of the study was to prove, that assessment of the thyroid hormones in every vomiting woman in the first trimester allows to start the proper treatment of hyperthyreosis as early as possible and improves the prognosis. MATERIALS AND METHODS: Authors analyzed 22 pregnant women treated for vomiting during the first trimester in the Department of Obstetrics and 5 women treated in the Outpatient Clinic. RESULTS: In none of them hormonal dysfunction was diagnosed before pregnancy. In 21 patients free thyroxine (fT4) in serum was assessed. In 8 cases (38%) hyperthyreosis was diagnosed. Except the routine anti vomiting treatment, they received a beta-blocker 30 mg per day. It allowed to avoid hospitalization in three pregnant women treated in the outpatient clinic. Two patients, who had earlier two spontaneous abortions, delivered healthy babies. CONCLUSIONS: 1. The beta-blocker in treatment gives very good results and allows to avoid hospitalization in patients with hyperthyroidism and hyper emesis gravidarum. 2. In some patients vomiting may be the only symptom of sub clinical hyperthyroidism in early pregnancy. Assessment of the thyroid hormones levels and adequate treatment may give these women a chance for a healthy child.

Adolescent↗

Postoperative nausea and vomiting in patients undergoing total abdominal hysterectomy under spinal anaesthesia: a randomized study of ondansetron prophylaxis.

BACKGROUND AND OBJECTIVE: Patients undergoing total abdominal hysterectomy under general anaesthesia have a high risk of developing postoperative nausea and vomiting (PONV). The aim of this study was to evaluate the incidence of PONV in patients undergoing total abdominal hysterectomy under spinal anaesthesia with intravenous patient-controlled analgesia (PCA) using morphine and to compare its incidence with and without antiemetic prophylaxis. METHODS: Thirty-four patients undergoing total abdominal hysterectomy under spinal anaesthesia with i.v. PCA morphine postoperatively were divided into two groups. The first (n = 17) received ondansetron prophylaxis near the end of surgery while the second (n = 17) received no prophylaxis. Morphine consumption, emetic episodes (on a 3-point scale), patient satisfaction (visual analogue score), sedation and pruritus were evaluated 2, 4, 6, 9, 12, 18 and 24h postoperatively. RESULTS: Patient characteristics, postoperative morphine consumption (43.3 +/- 7.6 vs. 40.3 +/- 12.3 mg) and peristaltic recovery time (16.9 +/- 5 vs. 18.4 +/- 5.2 h) were similar in both groups. Overall nausea and vomiting were significantly lower in the ondansetron prophylaxis group than in the group without prophylaxis (52.9% vs. 88.2%, P < 0.05). Though nausea alone was higher in the prophylaxis group (41.2% vs. 29.4%), nausea with vomiting was significantly lower in the prophylaxis group (11.8% vs. 58.8%, P < 0.01). Patients' satisfaction scores were higher in the ondansetron group at all times and the difference was significant (P < 0.05) 4 h postoperatively. CONCLUSIONS: The incidence of PONV in patients undergoing total abdominal hysterectomy under spinal anaesthesia with i.v. PCA morphine is very high (88.2%). Antiemetic prophylaxis with ondansetron is highly recommended in this patients group resulting in a lower incidence of nausea and vomiting, and significantly improves patient' satisfaction and life quality in the early postoperative period.

Analgesia, Patient-Controlled↗

A pilot investigation of the psychologic functioning of patients with anticipatory vomiting.

A pilot investigation of nine cancer patients receiving chemotherapy on an outpatient basis at the University of Florida's Shands Teaching Hospital is reported. The focus of the study was comparing patients with anticipatory vomiting symptoms with patients who did not exhibit prechemotherapy vomiting on measures of affect and coping style. The data indicated that patients exhibiting prechemotherapy vomiting, compared with the other patients, were more anxious and depressed; additionally, they exhibited a coping style which was inhibitive rather than facilitative in nature. A theoretical context for defining and treating prechemotherapy vomiting is offered.

Antineoplastic Agents↗

Intravenous metoclopramide: prevention of chemotherapy-induced nausea and vomiting. A preliminary evaluation.

The authors tested the safety and efficacy of intravenous metoclopramide in the prevention of chemotherapy-induced nausea and vomiting. Those studied included hospitalized patients receiving their initial treatment with potent, emetogenic non-cisplatin-containing regimens, and outpatients receiving both their initial and maintenance non-cisplatin-containing chemotherapy. Fifty patients received metoclopramide with one or more of three intravenous metoclopramide dosage schedules, based on whether they received their chemotherapy on an inpatient or outpatient basis. Of the 50 patients treated, 39 (78%) achieved total protection (no emesis), and 9 (18%) attained major antiemetic protection (one or two emeses) when all dosage schedules of metoclopramide were combined. Therefore, total or major antiemetic protection was observed in 48 of 50 patients (96%) receiving a broad range of potentially emetogenic chemotherapy. Antiemetic protection was shown not to depend on the schedule of metoclopramide dosing used, but rather on the emetic potential of the chemotherapeutic agents or combinations employed. In addition, previously treated patients in whom chemotherapy-related nausea or vomiting had posed a significant problem in the past, were shown to have an overall lower incidence of total antiemetic and antinausea protection as compared with patients who were previously untreated or did not experience emesis with prior chemotherapy. Thirty patients experienced no nausea or vomiting with intravenous metoclopramide; in the 20 patients who experienced nausea, its incidence was shown to be directly proportional to the emetic potential of the chemotherapy agents employed. Side effects were dose-related, however none were serious enough to warrant drug withdrawal. It is concluded that intravenous metoclopramide possesses significant antiemetic activity in patients receiving potent, non-cisplatin-containing chemotherapy. The dosage and scheduling required to provide total protection against nausea and vomiting appears to be dependent on the inherent emetic potency of the chemotherapy used. Further studies involving large numbers of patients are required to determine the optimal dosage and scheduling of this agent.

Antineoplastic Agents↗

Efficacy of ondansetron against nausea and vomiting caused by dacarbazine-containing chemotherapy.

BACKGROUND AND METHODS: The antiemetic activity of ondansetron (Zofran, Glaxo Pharmaceuticals, Research Triangle Park, NC) was evaluated in 25 patients with recurrent melanoma who were treated sequentially with dacarbazine (DTIC), vinblastine, and cisplatin. The antiemetic regimen included ondansetron alone in 11 patients; ondansetron plus lorazepam (Ativan, Wyeth-Ayerst, Philadelphia, PA) in 9 patients; and ondansetron plus lorazepam plus metoclopramide (Reglan, A. H. Robins Co., Richmond, VA) in 5 patients. Twenty-one patients had no prior exposure to chemotherapy, whereas 4 patients had previously received the same chemotherapy regimen and had severe vomiting despite administration of standard antiemetics. RESULTS: The antiemetic efficacy of ondansetron was impressive. Administration of a single dose of 10 mg resulted in complete control of nausea and vomiting in 22 patients, and the remaining 3 patients had only mild vomiting. CONCLUSIONS: Ondansetron is highly effective in controlling the nausea and vomiting caused by dacarbazine.

Adolescent↗

Granisetron is equivalent to ondansetron for prophylaxis of chemotherapy-induced nausea and vomiting: results of a meta-analysis of randomized controlled trials.

BACKGROUND: The introduction of serotonin antagonists as antiemetics for prophylaxis of chemotherapy-induced nausea and vomiting represented a major step toward better patient tolerance and adherence to this type of treatment. Several published trials compared different serotonin antagonists without demonstrating clear superiority of any one of them. Because most of these trials compared ondansetron with granisetron, the authors conducted a meta-analysis to determine if the current data available show any therapeutic difference between them. METHODS: MEDLINE and CANCERLIT databases were searched from 1990 to May 1999, and pertinent article references also were surveyed, without restriction to English language. The authors included all randomized controlled trials (RCTs) that had more than 25 patients per arm and compared ondansetron to granisetron for prophylaxis of acute (A) (< 24 hours) and delayed (D) (> 24 hours) nausea (N) and vomiting (V) induced by highly (H) or moderately (M) emetogenic chemotherapy. Only the first chemotherapy cycle was considered for studies that involved a crossover design. RESULTS: Fourteen studies with 6467 evaluable patients among the 21 studies retrieved were selected for this meta-analysis. In none of the eight scenarios studied (AHV, AHN, AMV, AMN, DHV, DHN, DMV, and DMN) could the authors detect any significant differences in the antiemetic efficacy of any of these medications. CONCLUSIONS: The authors conclude that both granisetron and ondansetron have similar antiemetic efficacy for prophylaxis of chemotherapy-induced nausea and vomiting. Because the number of comparative studies that addressed the delayed nausea and vomiting scenarios is low, further RCTs are still needed to confirm these results.

Antiemetics↗

Significance of vomiting for hyperamylasemia and sialadenosis in patients with eating disorders.

The authors investigated the significance of vomiting for hyperamylasemia and sialadenosis in patients with bulimia nervosa. Hyperamylasemia was found in 61% of the bulimics and in 20% of the restrictor anorectics but in no patients with binge-eating syndrome. In more than three fourths of the bulimics there was a close positive correlation between the frequency of vomiting and total serum amylase levels. Both frequency and type of vomiting seem to be relevant to the extent of salivary gland enlargement. The significance of vomiting for the etiopathology of hyperamylasemia and for the diagnosis of eating disorders will be discussed.

Adult↗

An apomorphine-induced vomiting model for antiemetic studies in man.

Apomorphine-induced vomiting is often used for preclinical efficacy testing of putative antiemetics in normal volunteers. The usual technique of individual intravenous titration for finding the threshold emitic dose of apomorphine in each subject is slow and tedious. We used a uniform dose of 0.05 mg/kg apomorphine given subcutaneously to test the antiemetic action of metoclopramide and votracon in ten healthy, young male volunteers. All ten subjects vomited in response to this dose of apomorphine when pretreated with placebo. Pretreatment with metoclopramide prevented vomiting in all subjects, and votracon prevented vomiting in two. Apomorphine, 0.05 mg/kg, subcutaneously appears to be an appropriate challenge dose for testing compounds for antiemetic activity in normal human volunteers.

Adult↗