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Variables related to nausea and vomiting during pregnancy.

Seventy to 90 percent of all pregnant women experience nausea, and 50 percent have at least one episode of vomiting or retching. A continuous measure was used to quantify symptoms of nausea with or without vomiting or retching during pregnancy in 126 women. Relationships between symptoms and selected variables were evaluated. Nausea with or without vomiting or retching was associated with maternal age, occupation, parity, cigarette smoking, infant gender, and the personality trait of independence. Significant associations were entered into multiple regression equations. Fourteen percent of the variation in symptoms overall, 25.1 percent of the variation in nausea symptoms, and 16.6 percent of the variation in vomiting or retching symptoms were explained by a combination of these selected independent variables. Although this study found associations, independent variables contributed little to predicting or explaining the presence and severity of nausea and vomiting during pregnancy. More sensitive measures and evaluation are required to understand and treat this perplexing phenomenon.

Female↗

Intermediate dose metoclopramide is not more effective than standard dose metoclopramide for patients who present to the emergency department with nausea and vomiting: a pilot study.

OBJECTIVE: To determine whether intermediate dose metoclopramide is more effective than standard dose metoclopramide for patients who present to the ED with nausea and vomiting. METHODS: This prospective, single-blind, randomized trial was conducted in the ED of two community teaching hospitals in a convenience sample of adult patients who presented to ED with nausea and vomiting. Patients were randomized to receive either 10 mg metoclopramide IV or 0.4 mg/kg IV (up to a maximum dose of 32 mg). The outcomes measured were: change in nausea score (measured on a 11-point verbal rating scale), requirement for other anti-emetic drug administration, and presence of side-effects. RESULTS: Fifty-eight patients were eligible for analysis (34 in 10 mg group and 24 in 0.4 mg/kg group). Median reduction in nausea score in 10 mg group was four (range 0-10, 95% CI 3-5) compared with five for 0.4 mg/kg group (range -1-10, 95% CI 4-6). This difference was not statistically significant (P = 0.629). Five patients in the 10 mg group required rescue anti-emetic, compared with three in the 0.4 mg/kg group (P = 1.00). There were no side-effects in the 10 mg group and two in the 0.4 mg/kg group. CONCLUSION: This study suggests that there is no difference in effectiveness between 10 mg and 0.4 mg/kg of metoclopramide in the ED population with nausea and vomiting.

Adolescent↗

Acupuncture and acupressure for the management of chemotherapy-induced nausea and vomiting.

PURPOSE: To review existing research, the National Institutes of Health (NIH) consensus statement, and federal regulations regarding the use of acupuncture and acupressure in the management of chemotherapy-induced nausea and vomiting in order to give nurse practitioners (NPs) the information they need to provide the best care for patients undergoing chemotherapy treatment for cancer. DATA SOURCES: Selected scientific literature and Internet sources. CONCLUSIONS: Research supports the effectiveness of acupuncture and acupressure for the treatment of chemotherapy-induced nausea and vomiting. Used in conjunction with current antiemetic drugs, acupuncture and acupressure have been shown to be safe and effective for relief of the nausea and vomiting resulting from chemotherapy. IMPLICATIONS FOR PRACTICE: Even with the best antiemetic pharmacological agents, 60% of cancer patients continue to experience nausea and vomiting when undergoing chemotherapy treatments. Because the NIH supports the use of acupuncture for nausea and vomiting, the NP is obligated to be knowledgeable about the use of these and other effective complementary treatments in order to provide the best care.

Acupressure↗

Anticipatory nausea and vomiting: are psychological factors adequately investigated?

Current research on chemotherapy-induced nausea and vomiting in cancer patients is reviewed, and some hypotheses to explain why anticipatory and post-chemotherapy nausea and vomiting appear are suggested. Methodological problems are also discussed. It is suggested that future research should focus on post-chemotherapy nausea and emesis, rather than anticipatory nausea and emesis, in order to achieve a deeper understanding of the psychological factors involved in the development of chemotherapy-induced nausea and vomiting.

Adaptation, Psychological↗

Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials.

OBJECTIVE: To determine how many patients were deprived of treatment by being given placebo as comparator in trials of ondansetron for postoperative nausea and vomiting. DESIGN: Review of published trials of ondansetron during 1991 to July 1994. SETTING: Medline search in a university department of anaesthesia. SUBJECTS: 8806 patients who had been included in 18 indexed placebo controlled trials of ondansetron as prophylaxis against or treatment of postoperative nausea and vomiting. RESULTS: Five studies (1236 patients) had been published by July 1992. All were placebo controlled trials. By July 1994, 8806 patients had been included in 18 indexed placebo controlled studies of prophylaxis or treatment. Only 462 patients had been in studies that compared ondansetron with other drugs, and there were no indexed comparative trials of treatment of nausea and vomiting. Roughly 2180 patients had been given placebo as prophylaxis and 440 had been given placebo when already experiencing postoperative nausea or vomiting. CONCLUSIONS: Around 2620 patients in the reviewed studies were denied existing drugs, which, though not completely effective or without side effects, do bring some relief from postoperative nausea and vomiting. Drug regulatory bodies should collaborate with drug companies to ensure better comparison of new with established drugs. This would avoid placebos being given to more than the fewest patients necessary to confirm effect and would allow doctors to be informed more quickly about relative efficacies.

Anesthesia Department, Hospital↗

A quantitative systematic review of ondansetron in treatment of established postoperative nausea and vomiting.

OBJECTIVES: To test the evidence for a dose-response with ondansetron for treatment of postoperative nausea and vomiting and to establish whether differences in efficacy between doses are of clinical relevance. DESIGN: Quantitative systematic review of published randomised controlled trials. DATA SOURCES: Seven trials from 1991 to January 1996 retrieved from a systematic literature search (Medline, reference lists, hand searching of anaesthetic journals, manufacturer's database); no restriction on language. MAIN OUTCOME MEASURES: Estimation of efficacy (incidence of complete control of further nausea and vomiting) by using odds ratios and the "number needed to treat" method for early (within 6 hours of administration) and late (within 24 hours) periods. RESULTS: Four placebo controlled trials with 1043 patients studied intravenous ondansetron 1 mg, 4 mg, or 8 mg. All doses were more efficacious than placebo in preventing further episodes of nausea or vomiting. For combined data, the point estimates for the number needed to treat were between 3.1 (8 mg) and 3.8 (1 mg) for early efficacy and between 4.1 (8 mg) and 4.8 (1 mg) for late efficacy, without significant differences between doses. No difference was found between ondansetron and droperidol in two trials with 129 patients or between ondansetron and metoclopramide in one trial with 80 patients. CONCLUSIONS: Further nausea and vomiting could be prevented with ondansetron compared with placebo in 25% of patients who had nausea or vomiting (number needed to treat, about 4). There was no evidence of a clinically relevant dose-response between 1 mg and 8 mg or a difference between ondansetron and either droperidol or metoclopramide in a limited dataset. A false impression of ondansetron's efficacy may arise because a quarter of all relevant published reports are duplicates, and reporting of study results is uncritical.

Antiemetics↗

Digestive tract motor correlates of vomiting and nausea.

The digestive tract from the upper esophageal sphincter to the ileum participates in the vomiting process, but the role of the digestive tract in nausea is unclear. In preparation for vomiting, the proximal stomach relaxes and the small intestine is evacuated orad in a single mass movement by a retrograde giant contraction and caudad in a stripping fashion by a series of phasic contractions. Orad evacuation of the small intestine may not only remove offending substances but may also dilute. or buffer gastric contents with intestinal and pancreaticobiliary secretions. In association with retching and vomiting, the striated muscle of the esophagus contracts longitudinally, pulling the relaxed proximal stomach into the thoracic cavity forming a funnel from stomach to esophagus. However, gastric evacuation does not occur until the hiatal fibers of the diaphragm relax during vomitus expulsion. Nausea is a subjective feeling in humans that is difficult to identify in animals. Various changes in digestive tract activity have been associated with nausea, but no evidence suggests that these events cause nausea. The prodromal signs of vomiting (e.g., increased heart rate and respiration) that occur concomitantly with the gastrointestinal motor correlates of vomiting have been considered autonomic indices of nausea in animals, but this has not been proven. Regardless, the gastrointestinal motor correlates of vomiting do not cause the prodromata. The emetic central pattern generator may be organized in parallel with respect to its individual autonomic correlates, but as groups of responses, the autonomic and somatomotor correlates may be organized in series.

Animals↗

Higher plasma 5-hydroxyindoleacetic acid levels are associated with SSRI-induced nausea.

We investigated the association between selective serotonin reuptake inhibitors (SSRIs; paroxetine or fluvoxamine) and nausea with regard to plasma 5-hydroxyindoleacetic acid (p5-HIAA) levels. Forty-eight patients meeting the DSM-IV criteria for major depressive disorder and treated with paroxetine or fluvoxamine participated in this study. p5-HIAA levels after SSRI administration were significantly higher in the nausea group than those in the nonnausea group (nausea group: 8.0 +/- 4.6 ng/ml; nonnausea group: 3.6 +/- 2.2 ng/ml; p < 0.01). On the other hand, no significant difference was found between the nausea and nonnausea group in terms of p5-HIAA levels before each drug administration. These results suggest that SSRI-induced nausea is associated with serotonergic hyperactivity in the gastrointestinal tract.

Acetophenones↗

Pregnancy nausea related to women's obstetric and personal histories.

We report the correlation between total hours of nausea in early pregnancy, as a continuous variable, and various factors in women's obstetric and personal histories. Positive correlations for increased nausea were found with heavier placentae (p = 0.005), non-smoking status (p = 0.004), women with nausea in previous pregnancies (p = 0.005), and women whose mothers experienced trouble with nausea in their pregnancies (p = 0.001). 17 other factors did not relate to pregnancy nausea at the p < 0.01 level.

Female↗

Ondansetron 4 mg for the prevention of nausea and vomiting after minor laparoscopic gynaecological surgery.

We studied the efficacy and safety of intravenous ondansetron 4 mg for the prevention of postoperative nausea and vomiting after minor gynaecological laparoscopic surgery in Oriental women. This double-blind randomised study compared ondansetron with placebo, given before the induction of anaesthesia. The anaesthetic technique used thiopentone, fentanyl, atracurium, nitrous oxide and isoflurane. Patients were studied for 24 h with nausea assessed using a verbal numeric scale from 0-10 and emetic episodes recorded as they occurred. Results were available for 102 patients in each group. In the first postoperative hour, fewer patients in the ondansetron Group (12%) had emetic episodes compared with the placebo group (33%, P < 0.01). Nausea score over the first hour (sum of three readings at 0, 30 and 60 min) was lower in the ondansetron group (median 1.6) compared with the placebo group (3.1, P < 0.05). Over the 24 h period, fewer patients in the ondansetron group had emetic episodes (25%) or nausea (43%) compared with patients in the placebo group (56%, P < 0.01) and (58%, P < 0.05) respectively. No adverse events were seen. Ondansetron 4 mg was more effective than placebo in preventing postoperative nausea and vomiting throughout the 24 h after minor laparoscopic surgery.

Adult↗

A double-blind randomized controlled trial of ginger for the prevention of postoperative nausea and vomiting.

The efficacy of ginger for the prevention of postoperative nausea and vomiting was studied in a double-blind, randomized, controlled trial in 108 ASA 1 or 2 patients undergoing gynaecological laparoscopic surgery under general anaesthesia. Patients received oral placebo, ginger BP 0.5g or ginger BP 1.0g, all with oral diazepam premedication, one hour prior to surgery. Patients were assessed at three hours postoperatively. The incidence of nausea and vomiting increased slightly but nonsignificantly with increasing dose of ginger. The incidence of moderate or severe nausea was 22, 33 and 36%, while the incidence of vomiting was 17, 14 and 31% in groups receiving 0, 0.5 and 1.0g ginger, respectively (odds ratio per 0.5g ginger 1.39 for nausea and 1.55 for vomiting). These results were essentially unchanged when adjustment was made for concomitant risk factors. We conclude that ginger BP in doses of 0.5 or 1.0 gram is ineffective in reducing the incidence of postoperative nausea and vomiting.

Adjuvants, Anesthesia↗

Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis.

OBJECTIVE: To report the incidence of postoperative nausea and vomiting (PONV), to describe the use of anti-emetics both for the prophylaxis and treatment of PONV, and to assess resource utilization and duration of post-anesthesia care unit (PACU) stay. RESEARCH DESIGN AND METHODS: We retrieved data from the Duke Anesthesia Peri-operative database. We included adult patients, who underwent inpatient surgery under general anesthesia with inhaled agents between January 2004 and February 2005, and had two or more risk factors for PONV documented preoperatively (female, previous history of PONV or motion sickness, non-smoker or use of postoperative opioid). Data on the use of prophylactic anti-emetics, the incidence of PONV, nausea scores, pain scores, and the use of rescue anti-emetics in PACU and in the period between PACU discharge and 24 h after surgery were recorded. Resource utilization and cost assessment was performed from the perspective of the hospital and included length and direct cost of PACU stay, as well as the acquisition costs of rescue anti-emetics in PACU. Descriptive statistics were used to summarize the demographic characteristics of patients. For group comparisons, data were analyzed with the t-test for continuous data, and the Chi-square test for categorical data. Multiple linear regression models were used to evaluate the association between PONV and PACU length of stay adjusting for confounding factors. RESULTS: A total of 3641 patients were included in the analysis. Of those, 2869 (79%) received prophylactic anti-emetics. In the PACU, nausea and vomiting were reported in 16% and 3% of the patients, respectively. Rescue anti-emetics were given to 26% of all patients. The incidence of vomiting was significantly less in patients who received PONV prophylaxis (p = 0.03). In multiple linear regression models, the duration of PACU stay was longer by a mean of 25 min in patients who experienced PONV or received rescue anti-emetics in PACU (p < 0.0001) despite the fact that the duration of surgery was shorter by a mean of 24 min in this group of patients (p < 0.0001). Following PACU discharge, 40% of patients reported nausea, vomiting or needed rescue anti-emetics. PONV was associated with significantly increased resource utilization and costs of PACU stay (p < 0.0001). Emesis was associated with greater incremental cost (138 US dollars) than nausea (85 US dollars), mainly from the longer duration of PACU stay. CONCLUSIONS: PONV remain a significant problem postoperatively and often persists beyond PACU discharge. The presence of PONV is associated with increased length of PACU stay and greater resource utilization and costs.

Adult↗

Antagonism of serotonin S3 receptors with ondansetron prevents nausea and emesis induced by cyclophosphamide-containing chemotherapy regimens.

The control of nausea and emesis in cancer patients receiving chemotherapy poses a significant management problem. In this randomized, double-blind, placebo-controlled study, we evaluated the effect of serotonin S3 receptor blockade with ondansetron (GR 38032F) on the prevention of nausea and vomiting induced by cyclophosphamide-containing chemotherapy. Cyclophosphamide was given in doses of 500 to 600 mg/m2 and ondansetron as three intravenous (IV) doses of 0.15 mg/kg. Most patients had breast cancer. Cyclophosphamide was given in combination with doxorubicin (65% of patients) or with fluorouracil (85% of patients: 50% with Adriamycin [doxorubicin; Adria Laboratories, Columbus, OH] and 35% with methotrexate). All placebo-treated patients experienced vomiting, whereas 70% of patients treated with ondansetron did not vomit (P = .008). Median nausea scores were 8 mm on ondansetron and 65 mm on placebo (P less than .001). Seventy percent of patients treated with ondansetron retained their normal appetite, compared with 10% of placebo patients. Adverse events occurred in six placebo patients and one ondansetron patient. Diarrhea and headache were the most common events, both occurring more frequently in the placebo group. There were no extrapyramidal reactions, and the only significant biochemical change occurred in a placebo-treated patient. These results suggest that serotonin S3 receptor antagonists represent a novel, effective, and safe mode of therapy for nausea and emesis induced by cyclophosphamide-containing chemotherapies. In addition, our observations are compatible with the view that serotonin, acting on S3 receptors, mediates the nausea and emesis occurring after cyclophosphamide chemotherapy.

Adult↗

Effect of schedule and maintenance on the antiemetic efficacy of ondansetron combined with dexamethasone in acute and delayed nausea and emesis in patients receiving moderately emetogenic chemotherapy: a phase III trial by the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: This study examines whether the schedule of ondansetron significantly influences its antiemetic efficacy in the first 24 hours after chemotherapy, whether the administration of oral ondansetron after 24 hours is effective in preventing delayed emesis, and whether the efficacy of ondansetron is preserved over multiple courses of moderately emetogenic chemotherapy. PATIENTS AND METHODS: A multicenter double-blind study randomized 302 cancer patients to one of three treatment arms. Arm A received dexamethasone 10 mg intravenously (i.v.) plus ondansetron (Zofran; Glaxo Canada Inc, Toronto, Canada) 8 mg i.v. prechemotherapy plus ondansetron 8 mg orally every 12 hours postchemotherapy for nine doses. Arm B received dexamethasone 10 mg i.v. plus ondansetron 16 mg i.v. prechemotherapy plus placebo orally postchemotherapy in the same schedule as arm A. Arm C received dexamethasone 10 mg i.v. plus ondansetron 8 mg prechemotherapy plus ondansetron 8 mg orally postchemotherapy for one dose followed by placebo orally every 12 hours for eight more doses. Response was assessed by the number of reported episodes of vomiting and by severity of nausea measured on a visual analog scale (VAS). RESULTS: The two schedules of ondansetron used in the first 24 hours were no different in their antiemetic efficacy, with similar rates for complete responses (76.7% v 72.0%, P = .472), complete plus major responses (90.2% v 82.0%, P = .135), and severity of nausea (P = .348). Oral ondansetron after 24 hours was more effective than placebo in preventing delayed nausea and emesis, with superior rates of complete responses (59.6% v 42.1%, P = .012 by one-sided test), complete plus major responses (80.9% v 66.3%, P = .018 by one-sided test), and less severe nausea (9.2 mm v 18.6 mm on a 100-mm VAS, P = .002). The efficacy of ondansetron was maintained over subsequent courses of chemotherapy. CONCLUSION: The schedule of ondansetron in the first 24 hours does not influence its efficacy. The use of oral maintenance ondansetron is effective in preventing delayed maintenance ondansetron is effective in preventing delayed nausea and emesis after moderately emetogenic chemotherapy.

Antineoplastic Agents↗

Prophylactic transdermal scopolamine patches reduce nausea in postoperative patients receiving epidural morphine.

To evaluate the efficacy of prophylactic transdermal scopolamine in reducing nausea associated with postoperative epidural analgesia, we studied 32 healthy adult women undergoing major gynecologic surgery. The patients were randomized in a double blind fashion to receive either a cutaneous scopolamine patch or a visually identical cutaneous placebo patch. Postoperative analgesia was provided solely with epidural morphine. Nausea was treated with metoclopramide and droperidol. At 24 hours postoperatively, the mean nausea score was significantly lower with scopolamine than with placebo (1 +/- 2 vs 51 +/- 42, respectively, P less than 0.05). The number of patients reporting "zero nausea" was significantly greater with scopolamine patches than with placebo patches (13 vs 1, P less than 0.01). The mean number of times antiemetic drugs were administered per patient was lower with scopolamine than with placebo patches (0.2 +/- 0.4 vs 2.8 +/- 2.6, P less than 0.05). It is concluded that prophylactic transdermal scopolamine patches reduce nausea in postoperative patients receiving epidural morphine.

Administration, Cutaneous↗

Prevention of postoperative nausea and vomiting using ondansetron, a new, selective, 5-HT3 receptor antagonist.

The effect of ondansetron, a 5-HT3 antagonist, in preventing postoperative nausea and vomiting was investigated in a randomized, double-blind, placebo-controlled study of 84 patients undergoing gynecologic operation and receiving the same general anesthetic. The patients received premedication with either 16 mg oral ondansetron, or a matching placebo. The same medication was given postoperatively 8 h after the first dose. During the first hour after recovery from anesthesia, the frequencies of nausea and vomiting were 52% and 40%, respectively, in patients given placebos. In the ondansetron group nausea and vomiting developed in 17% and 12%, respectively, values significantly different from those with placebos (P less than 0.005). Similar differences were observed throughout the entire 24-h period after recovery, the incidence of nausea and vomiting being 67% and 60%, respectively, in the placebo group and 29% and 26% in the ondansetron treatment group. Ondansetron appears to be a promising antiemetic for the prevention of postoperative nausea and vomiting.

Adult↗

Prophylaxis of postoperative nausea and vomiting with oral, long-acting dimenhydrinate in gynecologic outpatient laparoscopy.

UNLABELLED: Dimenhydrinate is an inexpensive antiemetic with few side effects available as an oral, long-acting (LA) formulation (Gravol L/A) containing 25 mg of immediate and 50 mg of sustained release drug. We designed this double-blind comparison trial to assess the efficacy of dimenhydrinate LA versus droperidol alone and the combination for prophylaxis of nausea, vomiting, and retching in outpatient gynecologic laparoscopy. One-hundred-forty-one women were randomized into 3 groups: 1) droperidol (placebo capsule preoperatively and IV droperidol 0.625 mg before induction), 2) dimenhydrinate LA preoperatively and IV placebo before induction, or 3) combination. Information regarding nausea, vomiting, retching, pain, and sedation was recorded in the postanesthesia care unit (PACU) and collected by telephone for the presence of symptoms: on arrival home; at bedtime; upon arising, and at lunchtime the following day. The overall incidence of complete treatment failure (rescue medication in PACU or nausea, vomiting, or retching at any time point) was 28 of 46 (61%), 28 of 48 (58%), and 22 of 47 (47%); and for treatment failure vomiting (rescue medication in PACU or vomiting or retching at any time point) was 16 of 46 (35%), 11 of 48 (23%), and 5 of 47 (11%), for the droperidol, dimenhydrinate, and combination groups, respectively (P = 0.007 for droperidol versus combination). There were no differences in sedation or pain. Preoperative administration of an oral dose of LA dimenhydrinate in combination with droperidol when compared with droperidol alone effectively reduced the incidence of vomiting but not nausea in women undergoing elective outpatient gynecologic laparoscopy. IMPLICATIONS: Dimenhydrinate is an inexpensive antiemetic with few side effects available as a long-acting oral formulation. Women undergoing outpatient gynecologic laparoscopy were given droperidol, an effective antiemetic, dimenhydrinate alone, or the combination of the two drugs. Dimenhydrinate plus droperidol significantly reduced the overall incidence of vomiting, but not nausea, when compared with droperidol alone.

Administration, Oral↗

A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting.

In this study we evaluated the efficacy of electro-acupoint stimulation, ondansetron versus placebo for the prevention of postoperative nausea and vomiting (PONV). Patients undergoing major breast surgery under general anesthesia were randomized into active electro-acupoint stimulation (A), ondansetron 4 mg IV (O), or sham control (placement of electrodes without electro-acupoint stimulation; placebo [P]). The anesthetic regimen was standardized. The incidence of nausea, vomiting, rescue antiemetic use, pain, and patient satisfaction with management of PONV were assessed at 0, 30, 60, 90, 120 min, and at 24 h. The complete response (no nausea, vomiting, or use of rescue antiemetic) was significantly more frequent in the active treatment groups compared with placebo both at 2 h (A/O/P = 77%/64%/42%, respectively; P = 0.01) and 24 h postoperatively (A/O/P = 73%/52%/38%, respectively; P = 0.006). The need for rescue antiemetic was less in the treatment groups (A/O/P = 19%/28%/54%; P = 0.04). Specifically, the incidence and severity of nausea were significantly less in the A group compared with the other groups, and in the O group compared with the P group (A/O/P = 19%/40%/79%, respectively). The A group experienced less pain in the postanesthesia care unit, compared with the O and P groups. Patients in the treatment groups were more satisfied with their management of PONV compared with placebo. When used for the prevention of PONV, electro-acupoint stimulation or ondansetron was more effective than placebo with greater degree of patient satisfaction, but electro-acupoint stimulation seems to be more effective in controlling nausea, compared with ondansetron. Stimulation at P6 also has analgesic effects.

Adult↗