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A randomized, double-blind, placebo-controlled trial of ramosetron for preventing nausea and vomiting during termination of pregnancy.

Women undergoing general anesthesia for dilatation and curettage have a high risk for postoperative nausea and vomiting. We therefore evaluated the efficacy and safety of ramosetron, a new compound having serotonin receptor antagonist activity, for preventing nausea and vomiting in termination of pregnancy. Eighty women scheduled for dilatation and curettage received, in a randomized, double-blind manner, an intravenous placebo or ramosetron at three different doses (0.15 mg, 0.3 mg, 0.6 mg) at the end of surgery (n = 20 per group). Emetic episodes and safety were assessed. The percentage of patients who were emesis-free (no nausea, no retching, no vomiting) during 0-24 h after anesthesia was 55% with ramosetron 0.15 mg (P = 0.5), 85% with ramosetron 0.3 mg (P = 0.02), and 90% with ramosetron 0.6 mg (P = 0.007), compared with 50% in the placebo group. No clinically serious adverse events due to the study drugs were observed in any group. Our results suggest that ramosetron 0.3 mg is an effective antiemetic for prophylaxis against emetic symptoms after dilatation and curettage. Increasing the dose to 0.6 mg provides no further benefit.

Abortion, Induced↗

Control of nausea and vomiting with ondansetron in patients treated with intensive non-cisplatin chemotherapy for acute myeloid leukaemia.

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.

Acute Disease↗

An overview of randomised studies comparing 5-HT3 receptor antagonists to conventional anti-emetics in the prophylaxis of acute chemotherapy-induced vomiting.

Ten years after it was demonstrated in the ferret that cisplatin-induced emesis could be blocked by the selective 5-HT3 receptor antagonist MDL 72222, 5-HT3 receptor antagonists have become routine anti-emetic agents for chemotherapy-induced emesis. However, although in association with highly emetogenic, mainly cisplatin-containing regimens, the use of these agents is well justified, the net benefit of 5-HT3 receptor antagonists in association with moderately emetogenic regimens has not been that well clarified. Here, we present an overview of 30 randomised studies comparing 5-HT3 antagonists with the conventional anti-emetics in the prophylaxis of acute vomiting induced by cytotoxic chemotherapy. A meta-analysis showed that 5-HT3 antagonists reduce the risk of acute vomiting in comparison to conventional anti-emetics both with cisplatin treatments (15 trials; odds ratio 0.60; 95% confidence interval 0.51-0.70) and with moderately emetogenic treatments (11 trials; odds ratio 0.47; 95% confidence interval 0.39-0.58). The risk of acute vomiting seems to be further reduced when 5-HT3 antagonists are combined with dexamethasone.

Acute Disease↗

A double-blind crossover study comparing prophylactic intravenous granisetron alone or in combination with dexamethasone as antiemetic treatment in controlling nausea and vomiting associated with chemotherapy.

The efficacies of granisetron plus dexamethasone and granisetron alone in controlling nausea and vomiting during two consecutive cycles of moderately emetogenic chemotherapy given for up to 5 days were compared in a two-centre, randomised, double-blind, placebo-controlled crossover study. In all, 110 evaluable patients received either dexamethasone, 20 mg i.v., or matching placebo, plus open-label granisetron, 3 mg i.v., given on each chemotherapy day. At cycle 2, patients crossed over to the alternative treatment; 72 patients completed the crossover. In these 72 patients, the complete response rates over 24 h for granisetron plus dexamethasone and granisetron plus placebo in cycle 1 were 87% and 70% (ns), respectively. In cycle 2 the complete response rates over 24 h were 73% and 62% (ns). Combining the two cycles, the complete response rates over 24 h were 80.6% (granisetron plus dexamethasone) and 65.3% (granisetron plus placebo; P = 0.015). Granisetron plus dexamethasone was significantly more effective in terms of times to less than complete response (P = 0.041), to first episode of moderate/severe nausea (P = 0.04), to first episode of vomiting (0.03) and to use of rescue medication (P = 0.02). Adverse events tended to be minor, with asthenia and insomnia the most common. Of those patients who expressed a preference, 67% preferred granisetron plus dexamethasone (P < 0.05). A single dose of dexamethasone added to granisetron thus enhances the efficacy of granisetron alone in preventing nausea and vomiting after moderately emetogenic chemotherapy.

Adolescent↗

Using diazepam and atropine before strabismus surgery to prevent postoperative nausea and vomiting: a randomized, controlled study.

OBJECTIVE: To evaluate the efficacy of diazepam and atropine sulfate premedication in preventing nausea and vomiting after strabismus surgery under general anesthesia. METHODS: Fifty children age 4 to 15 years who underwent strabismus surgery at Cukurova University Medical Faculty, Department of Ophthalmology, from February 2000 to June 2000 were randomized into 2 groups: 25 children in the control group did not receive premedication, whereas 25 children in the treatment group received premedication with 0.15 mg/kg diazepam and 0.015 mg/kg atropine sulfate. Occurrence of postoperative nausea and vomiting (PONV) was recorded. RESULTS: The incidence of PONV was lower in the premedicated group (P <.018, chi(2) test). CONCLUSIONS: It is concluded that diazepam and atropine sulfate premedication decreases nausea and vomiting after strabismus surgery.

Anti-Anxiety Agents↗

Effect of acupressure on nausea, vomiting, anxiety and pain among post-cesarean section women in Taiwan.

The purpose of this study was to examine the effectiveness of acupressure for controlling post-cesarean section (CS) symptoms, such as nausea and vomiting, anxiety perception and pain perception. A total of 104 eligible participants were recruited by convenience sampling of operating schedules at two hospitals. Participants assigned to the experimental group received acupressure, and those assigned to the control group received only postoperative nursing instruction. The experimental group received three acupressure treatments before CS and within the first 24 hours after CS. The first treatment was performed the night before CS, the second was performed 2-4 hours after CS, and the third was performed 8-10 hours after CS. The measures included the Rhodes Index of Nausea and Vomiting, Visual Analog Scale for Anxiety, State-Trait Anxiety Inventory, Visual Analog Scale for Pain, and physiologic indices. Statistical methods included percentages, mean value with standard deviation, t test and repeated measure ANOVA. The use of acupressure reduced the incidence of nausea, vomiting or retching from 69.3% to 53.9%, compared with control group (95% confidence interval = 1.65-0.11; p = 0.040) 2-4 hours after CS and from 36.2% to 15.4% compared with control group (95% confidence interval = 0.59-0.02; p = 0.024) 8-10 hours after CS. Results indicated that the experimental group had significantly lower anxiety and pain perception of cesarean experiences than the control group. Significant differences were found in all physiologic indices between the two groups. In conclusion, the utilization of acupressure treatment to promote the comfort of women during cesarean delivery is strongly recommended.

Acupressure↗

Diclectin therapy for nausea and vomiting of pregnancy: effects of optimal dosing.

OBJECTIVES: (1) To quantify rates of suboptimal use of pyridoxine hydrochloride-doxylamine (Diclectin); and (2) to study responses to optimal doses of Diclectin in women previously taking a suboptimal dose. METHODS: Women who called the Motherisk NVP helpline, and were taking only Diclectin (vitamin B6 10 mg and doxylamine 10 mg), were enrolled in the study and assessed for the severity of nausea and vomiting of pregnancy (NVP) with the Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system. Their Diclectin doses were subsequently increased according to body weight and individual symptoms. A follow-up phone call occurred within 1 to 3 weeks after the intervention, at which time the overall PUQE score was repeated, along with individual scoring of symptoms of nausea, vomiting, and retching. RESULTS: Sixty-eight women were enrolled and completed the study. Despite moderate to severe NVP, defined by the validated PUQE scoring system, most women (50/68) were receiving 2 tablets a day of Diclectin instead of the recommended dose of 4 tablets a day. Following a mean doubling of the dose to 4 tablets a day, there was a significant decrease in length of nausea (from 4 to 3 hours, P < 0.001), frequency of vomiting (from mean 1.6 to 1.3 a day, P = 0.02), and overall PUQE score (from mean 7.5 to 6.1, P < 0.001). CONCLUSION: Women suffering from NVP are often given subtherapeutic doses of Diclectin. Women should receive a dosage according to their body weight and severity of their symptoms.

Adult↗

Winter vomiting disease in Florida students.

On 14 November 1967 an investigation was begun at the University of South Florida to determine the cause of an increased number of gastrointestinal illnesses on campus. An estimated 300 students suddenly became ill with nausea, vomiting, abdominal pain, and diarrhoea. While at first food poisoning was suspected, no common food, water, or toxic exposure could be found. The data collected were most consistent with Winter Vomiting Disease. This entity is characterized by acute gastrointestinal illnesses which may occur in epidemic form in residential schools between September and March. Most investigators suspect that a viral agent is responsible for the illnesses, though attempts to isolate a virus have been unsuccessful. The incubation period in the University outbreak was estimated at 28 hr., and contact was the most likely mode of transmission. The outbreak illustrated that Winter Vomiting Disease in residential institutions may be an accentuation of the gastrointestinal illnesses occurring simultaneously in the community at large.

Communicable Diseases↗

Oral ondansetron, tropisetron or metoclopramide to prevent postoperative nausea and vomiting: a comparison in high-risk patients undergoing thyroid or parathyroid surgery.

BACKGROUND: Oral antiemetic prophylaxis may be a practical alternative to intravenous administration. Intravenous ondansetron and tropisetron prevent postoperative nausea and vomiting (PONV) at least as efficiently as traditional antiemetics, droperidol and metoclopramide. We tested the hypothesis that the incidence of PONV after oral ondansetron or tropisetron prophylaxis is lower compared with metoclopramide among high-risk patients. METHODS: In a prospective, double-blind study we studied 179 high-risk patients who received either ondansetron 16 mg, tropisetron 5 mg, or metoclopramide 10 mg orally 1 h before the operation. A standard general anesthetic technique and postoperative analgesia were used. The incidence of PONV and the need for rescue antiemetic medication was recorded for 24 h. RESULTS: In the postanesthesia care unit, the incidence of PONV was lower after premedication with tropisetron compared with ondansetron and metoclopramide (15%, 32% and 39%, respectively). The incidence of PONV during 0-24 h was the same in each group (68%, 58% and 75% in the ondansetron, tropisetron and metoclopramide group, respectively), but the incidence of vomiting was significantly lower after ondansetron (34%) and tropisetron (22%) prophylaxis compared with metoclopramide (53%). The need for additional antiemetics was significantly lower after tropisetron prophylaxis compared with metoclopramide. Patient satisfaction was significantly higher after tropisetron than after metoclopramide. CONCLUSIONS: In the initial period, the incidence of PONV was lower after premedication with oral tropisetron than after ondansetron or metoclopramide. Considering the entire 24-h postoperative period, the incidence of PONV was the same after all three premedications, but the incidence of vomiting was lower after oral ondansetron and tropisetron than after metoclopramide.

Adult↗

Oral clonidine premedication does not reduce postoperative vomiting in children undergoing strabismus surgery.

BACKGROUND: We evaluated the effect of oral clonidine on postoperative vomiting (POV) in children undergoing strabismus surgery. METHODS: Eighty ASA physical status I children aged 3-12 years were randomly assigned to one of two groups in a double-blinded manner. One hour before surgery, each patient in the clonidine group (n=40) received clonidine 4 micro g kg-1 in apple juice 0.2 ml kg-1, and each of the controls (n=40) received apple juice 0.2 ml kg-1 only. The protocol for general anesthesia was propofol-sevoflurane in N2O/O2. A paracetamol suppository was administered in each case to prevent postoperative pain. Patient responses during 0-48 h after anesthesia were recorded as complete (no POV, no antiemetic rescue required), retching, vomiting, or rescue antiemetic. RESULTS: There were no significant differences between the clonidine and control groups regarding the number of patients with complete response (21 vs. 18, respectively) retching (10 vs. 14, respectively), vomiting (19 vs. 22, respectively), or rescue antiemetic (9 vs. 12, respectively) during the first 48 h. CONCLUSION: Oral premedication with clonidine 4 micro g kg-1 did not reduce the rate of POV in the children undergoing strabismus surgery.

Adrenergic alpha-Agonists↗

Comparing the effectiveness of behavioral treatment for chemotherapy-induced nausea and vomiting when administered by oncologists, oncology nurses, and clinical psychologists.

Adequate control of side effects during medical treatment of cancer increases patient compliance and quality of life. Antiemetic drugs are not an effective treatment for the one in three cancer patients on chemotherapy who experience anticipatory nausea and vomiting (ANV); the behavioral treatment of systematic desensitization has been found effective for ANV when delivered by clinical psychologists. This study examined the effectiveness of systematic desensitization when delivered by medical personnel versus clinical psychologists. Seventy-two consecutive cancer patients with ANV were randomly assigned to no-treatment control or to systematic desensitization from 5 behaviorally trained clinical psychologists, 6 clinical oncologists, or 10 oncology nurses. The treatment was found effective in reducing anticipatory nausea, anticipatory vomiting, posttreatment nausea, and posttreatment vomiting compared to control patients, with no significant differences in effectiveness found between clinical psychologists and oncology staff. Although medical personnel should not engage patients in psychotherapy or other interventions that cannot be completed successfully, they can treat patients effectively with systematic desensitization and should be encouraged to learn and use this and other behavioral intervention techniques to benefit total patient care.

Behavior Therapy↗

Dexamethasone can potentiate the anti-emetic action of a 5HT3 receptor antagonist on cyclophosphamide induced vomiting in the ferret.

A new group of selective 5HT3 antagonists are proving to be effective anti-emetics for cytotoxic and radiation induced vomiting in both animal models and man. Current anti-emetic regimens often benefit from combination therapy, in particular the efficacy of metoclopramide (which can be a weak 5HT3 antagonist), can be improved by combination with dexamethasone, another anti-emetic. Hence it was of interest to evaluate whether a 5HT3 receptor antagonist GR38032F could be improved by combination with dexamethasone. Vomiting induced by cyclophosphamide in the ferret was observed after pre-treatment with dexamethasone alone or in combination with GR38032F. Animals were also observed for signs of 'nausea'. Dexamethasone alone proved a weak anti-emetic in this system but did have significant effects on 'nausea'. GR38032F has previously been shown to be capable of totally controlling emesis due to cyclophosphamide in the ferret. Here a dose of GR38032F that is not 100% effective was employed; this was shown to have effects on 'nausea' but most interestingly its anti-emetic action was increased by combination with dexamethasone. This may be important for the minority of patients whose vomiting is not completely controlled by GR38032F alone.

Animals↗

Impact of tumour burden on chemotherapy-induced nausea and vomiting.

We investigated how residual tumour burden after cytoreductive surgery was related to the occurrence of acute and delayed nausea and vomiting in 101 ovarian cancer patients receiving their first chemotherapy course. The anti-emetic treatment included ondansetron combined with dexamethasone or placebo. After chemotherapy all patients received ondansetron only for 5 days. Two categories of tumour burden (TB) were formed according to the diameter of the greatest residual tumour (< 2 cm = minimal TB and > or = 2 cm = large TB). Self-reports of nausea and vomiting were obtained for 15 days. Other potential predictor variables were assessed and included in multivariate analyses. Patients with large compared with minimal TB had more delayed emesis, especially on days 2-7. They also had more acute nausea. The aggravating effect associated with large residual TB was more evident in patients > or = 55 years. During the second week after the chemotherapy the occurrence of nausea was higher in patients > or = 55 years than in those < 55 years. This was seen primarily in patients with large residual TB. Predictors for no delayed emesis at all were anti-emetic treatment with dexamethasone, minimal tumour burden, low neuroticism and no history of motion sickness. The increased risk of "persistent' delayed nausea and vomiting seen in older patients with large tumour burden may have important clinical implications and warrants further attention.

Adolescent↗

The association between the oculocardiac reflex and post-operative vomiting in children undergoing strabismus surgery.

The oculocardiac reflex (OCR) is a potentially serious complication of ophthalmic surgery which is most commonly elicited during paediatric strabismus surgery. Post-operative vomiting (POV) is also extremely common after such procedures and may result in admission following planned day-case surgery. Although many factors play a part in the occurrence of POV, stimulation of the trigemino-vagal reflex arc is thought to explain the particularly high rate of vomiting after strabismus surgery. The OCR and the vaso-vagal response share this neuronal pathway, the bradycardia of the OCR often being the only objective feature of the vaso-vagal response while the patient is anaesthetised. The aim of this study was to investigate the possible association between the occurrence of the OCR and subsequent POV in children undergoing strabismus surgery. We have studied this relationship in 79 children, aged between 1 and 13 years, undergoing strabismus surgery under standardised anaesthetic conditions. A positive OCR was regarded as a drop in heart rate of 10% or more, or the onset of a dysrhythmia. An intraoperative OCR was elicited in 51 (64.6%) of the 79 children, whilst 29 (36.7%) developed POV in the subsequent 24 h period. There was a significant association between a positive intraoperative OCR and POV (p = 0.01): children with a positive OCR were 2.6 times more likely to vomit than those without the reflex. We conclude that there is an association between the occurrence of the OCR and POV and discuss possible preventive strategies.

Adolescent↗

Comparison of three outpatient regimens in the management of nausea and vomiting in pregnancy.

OBJECTIVE: This study compares pyridoxine-metoclopramide combination therapy to prochlorperazine and promethazine monotherapies in the outpatient treatment of nausea and vomiting in pregnancy. STUDY DESIGN: In total, 174 first trimester, singleton pregnancies were evaluated for nausea and vomiting. Patients were prospectively randomized into three treatment groups: pyridoxine-metoclopramide, prochlorperazine, or promethazine. Prior to, and on the third day, patients recorded their subjective responses to the given treatment and their number of emesis episodes. The three treatment groups were compared for therapy response. RESULTS: There were no differences in the number of emesis episodes prior to treatment. Both subjective and objective responses to treatment differed among the three groups when comparing the combination therapy to the monotherapies (p<0.05). CONCLUSION: Combination therapy with pyridoxine and metoclopramide appears to be superior to either monotherapy in the treatment of nausea and vomiting in pregnancy.

Adult↗

The effect of smoking on postoperative nausea and vomiting.

In an attempt to quantify the postoperative effects of smoking, 327 consecutive patients undergoing arthroscopic day case knee surgery were given a standard anaesthetic consisting of an intravenous induction with propofol and fentanyl followed by inhalational maintenance using isoflurane in an oxygen and nitrous oxide mixture. Pre-operatively, patients were asked inter alia to give details of social smoking habits. Postoperatively, patients were given standard analgesic and anti-emetic drugs. Prior to discharge patients were asked to give details of postoperative nausea and vomiting together with details of the severity of postoperative pain. There were 85 smokers and 242 nonsmokers. Of the 327 patients, a total of 42 (13%) complained of postoperative nausea and vomiting. Of the smokers, only 6% complained of postoperative nausea and vomiting in contrast to 15% of the nonsmokers (p < 0.05). It is postulated that enzyme induction is the most likely reason for this anti-emetic effect. Possible ways in which this clinically beneficial mechanism can be utilised to improve outcome after anaesthesia are discussed.

Adult↗

Effect of cricoid pressure on the incidence of nausea and vomiting in the immediate postoperative period.

This study aimed to evaluate whether the application of cricoid pressure at the time of induction of anaesthesia was associated with a lesser incidence of postoperative nausea or vomiting in the immediate postoperative period compared with a group in which no cricoid pressure was applied, in patients undergoing day care gynaecological laparoscopy. One hundred ASA I and II females were randomly allocated to receive cricoid pressure at the time of induction. The peri-operative anaesthetic technique was standardised. The incidence of postoperative nausea and vomiting in the group who received cricoid pressure was 16% in the recovery room compared with 26% in the no cricoid group. When the period was extended to the first 6 h post anaesthesia the incidence was 30% in the cricoid and 44% in the no cricoid group. This difference did not achieve statistical significance in either period (p > 0.05). The results suggest that application of cricoid pressure at the time of induction does not significantly alter the incidence of postoperative nausea and vomiting in the first 6 h of recovery from anaesthesia.

Adolescent↗

Effect of supplemental pre-operative fluid on postoperative nausea and vomiting.

In a prospective, double-blind, randomised controlled trial, we studied the effects of pre-operative fluid load on post-operative nausea and vomiting. Eighty patients attending for laparoscopic cholecystectomy or gynaecological surgery were randomly allocated to receive 2 ml.kg-1 (conservative) or 15 ml.kg-1 (supplemental) Hartmann's solution intravenously, shortly before induction of anaesthesia. During the operation, fluid management was identical in both groups. During the first post-operative 24 h, post-operative nausea and vomiting occurred in 29 patients (73%) in the conservative fluid group and nine patients (23%) in the supplemental fluid group (p = 0.01). Supplemental pre-operative fluid is an inexpensive and safe therapy for reducing post-operative nausea and vomiting.

Adolescent↗