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PubMed1999

Prophylactic therapy with combined granisetron and dexamethasone for the prevention of post-operative vomiting in children.

This study was undertaken to compare the efficacy and safety of granisetron, a 5-hydroxytryptamine type 3 receptor antagonist, and dexamethasone and each drug alone for the prevention of post-operative vomiting by children, with no history of motion sickness and/or previous post-operative vomiting, undergoing general inhalational anaesthesia for surgery (inguinal hernia and phimosis). In a randomized, double-blind manner, 150 children, ASA physical status 1, aged 4-10 years, were assigned to receive granisetron 40 mg kg-1, dexamethasone 150 mg kg-1, or granisetron 40 mg kg-1 plus dexamethasone 150 mg kg-1 intravenously immediately after inhalation induction of anaesthesia (n = 50 of each). A complete response, defined as no emesis and no need for another rescue anti-emetic during the first 24 h after anaesthesia, was 86% with granisetron, 68% with dexamethasone and 98% with granisetron plus dexamethasone, respectively (P < 0.05; overall Fisher's exact probability test). No clinically serious adverse events were observed in any of the groups. In conclusion, prophylactic therapy with combined granisetron and dexamethasone was more effective than was each anti-emetic alone for the prevention of vomiting after paediatric surgery.

Anesthesia, Inhalation↗
PubMed1999

Comparison of ondansetron and tropisetron combined with droperidol for the prevention of emesis in women with a history of post-operative nausea and vomiting.

The anti-emetic efficacy of prophylactic ondansetron and tropisetron in combination with a low dose of droperidol in patients with high probability for post-operative nausea and vomiting undergoing gynaecological laparoscopy was compared. Patients were randomly allocated in a double-blind manner to receive either ondansetron 8 mg (n = 45) or tropisetron 5 mg (n = 43) at the end of surgery. A standardized general anaesthetic technique was used, including droperidol 0.75 mg. The incidence of nausea was 36% and 49% (P = 0.28), and vomiting occurred in 13% and 14% of the patients in the ondansetron and tropisetron groups, respectively. The onset time for rescue medication was significantly sooner after tropisetron than ondansetron (3 h 18 min vs. 6 h 25 min; P = 0.007). There were no statistically significant differences in efficacy between prophylactic ondansetron and tropisetron combined with droperidol in a high-risk population. However, ondansetron appeared to be more effective in preventing post-operative nausea and vomiting in the early hours after surgery compared with tropisetron.

Adult↗
PubMed1999

Prevention of post-operative nausea and vomiting with combined granisetron and droperidol in women undergoing thyroidectomy.

We have compared the efficacy and safety of combined granisetron and droperidol with each anti-emetic alone for preventing post-operative nausea and vomiting after thyroidectomy. In a prospective, randomized, double-blind study, 180 women received granisetron 40 micrograms kg-1, droperidol 20 micrograms kg-1, or granisetron 40 micrograms kg-1 plus droperidol 20 micrograms kg-1 (n = 60 of each) intravenously immediately before induction of anaesthesia. A standard general anaesthetic technique and post-operative analgesia were used. A complete response, defined as no post-operative nausea and vomiting and no need for another rescue anti-emetic, during the first 24 h after anaesthesia occurred in 88%, 60% and 98% of patients who had received granisetron, droperidol and granisetron plus droperidol (P < 0.05; overall Fisher's exact probability test). No clinically important adverse events due to the drugs were observed in any of the groups. In summary, prophylactic use of combined granisetron and droperidol is more effective than each drug alone for the prevention of post-operative nausea and vomiting in female patients undergoing thyroidectomy.

Adult↗
PubMed1999

Assessment of ondansetron and droperidol for the prevention of post-operative nausea and vomiting after cholecystectomy and minor gynaecological surgery performed by laparoscopy.

The anti-emetic effects of ondansetron and droperidol were evaluated in 134 ASA Grade I and II female patients, scheduled for laparoscopic cholecystectomy and minor gynaecological laparoscopic surgery, who were randomly assigned to receive ondansetron 4 mg or droperidol 75 micrograms kg-1 intravenously immediately after induction of anaesthesia. The patients were assessed 1, 6, 12 and 24 h after surgery for intensity of nausea and number of vomiting episodes. In the case of the patients undergoing laparoscopy, vomiting episodes occurred in a similar proportion in patients treated with ondansetron or droperidol, with the probability of the Type I error of 0.05 and the Type error II of 0.1. Although there was no difference between the two groups in emetic episodes following all laparoscopic procedures and gynaecological laparoscopic surgery, there was a significant difference between these parameters after laparoscopic cholecystectomy. The patients treated with ondansetron experienced a lower intensity of nausea (P = 0.04) after laparoscopic cholecystectomy, less frequent severe nausea (P = 0.02) and episodes of vomiting (P = 0.04) when compared with those in the droperidol group. We conclude, that despite the result the droperidol prophylaxis appears to be an effective alternative to ondansetron in all patients undergoing laparoscopy, the ondansetron prophylaxis is superior to droperidol in patients undergoing laparoscopic cholecystectomy.

Adult↗
PubMed2000

Efficacy of prophylactic droperidol, ondansetron or both in the prevention of postoperative nausea and vomiting in major gynaecological surgery. A prospective, randomized, double-blind clinical trial.

We conducted a prospective, randomized, double-blind clinical trial comparing droperidol 1.25 mg intravenously (i.v.) (group 1, n = 30), ondansetron 4 mg i.v. (group 2, n = 30), or both (group 3, n = 30) in the prevention of postoperative nausea and vomiting (PONV) in the first 24 h following major gynaecological procedures under combined general and epidural anaesthesia. PONV was analysed by a linear nausea/vomiting score, incidence of nausea and vomiting, and the need for antiemetic rescue. Our results showed a similar incidence of nausea and vomiting in all groups (G1 33%, G2 40%, G3 43%). However, when comparisons were made according to the time of assessment, combination therapy resulted in significantly lower PONV than droperidol in the first hour (0% vs. 13%, P < 0.05) and second hour (0% vs. 13%, P < 0.05), and than ondansetron on the first hour (0% vs. 13%, P < 0.05). A trend persisted up to the fourth hour but was not statistically significant in either group. In conclusion, droperidol and ondansetron are effective agents in the prevention of PONV, and their combination seems to provide slightly better results than either drug alone.

Adolescent↗
PubMed1999

Post-operative pain, nausea and vomiting: qualitative perspectives from telephone interviews.

Previous studies on post-operative pain, nausea and vomiting tend to be quantitative in method and focus on in-patient or day case surgery. The objectives of this study carried out in one specialist eye hospital in England were to consider post-operative pain, nausea and vomiting from a qualitative perspective. Fifty-five patients undergoing general anaesthetic short-stay ophthalmic surgery (orbital hydroxyapatite implantation) consented to participate in telephone interviews 8 days post-surgery. The interviews lasted between 20 and 60 minutes. Data were analysed thematically and offer insight into varying experiences of pain, nausea and vomiting in hospital, on discharge and at home. Results indicate that not all patients were discharged home in optimum condition. The needs of post-operative short-stay patients should come before financial imperatives to vacate beds. Patient education and information giving is discussed in the light of the findings.

Adult↗
PubMed1998

Comparison of granisetron and droperidol in the prevention of vomiting after strabismus surgery or tonsillectomy in children.

This prospective, randomized, double-blinded study evaluated the antiemetic efficacy of granisetron and droperidol in 80 ASA physical status I children, aged 4-10 years, undergoing strabismus surgery or tonsillectomy with or without adenoidectomy. After anaesthetic induction, the patients received either granisetron (40 micrograms.kg-1, n = 40) or droperidol (50 micrograms.kg-1, n = 40) intravenously. The incidence of vomiting during the first 24h after anaesthesia was 15% and 38% after administering granisetron and droperidol, respectively (P = 0.02). The requirement for rescue antiemetic therapy for the treatment of two or more episodes of vomiting was 0% with granisetron and 18% with droperidol (P = 0.001). In conclusion, granisetron was superior to droperidol in reducing the incidence and frequency of postoperative vomiting in paediatric patients.

Adenoidectomy↗
PubMed1999

Combination of granisetron and droperidol for the prevention of vomiting after paediatric strabismus surgery.

This study was undertaken to compare the efficacy of granisetron plus droperidol with each antiemetic alone for the prevention of vomiting after paediatric strabismus surgery. In a prospective, randomized, double-blinded trial, 120 ASA physical status I children, aged 4-10 years, received granisetron 40 microg.kg- 1, droperidol 50 microg.kg- 1, granisetron 40 microg.kg- 1 plus droperidol 50 microg.kg- 1 (n=40 of each) intravenously after an inhalation induction of anaesthesia. A complete response, defined as no vomiting, no retching and no need for another rescue antiemetic medication, during 0-3 h after anaesthesia was 80% with granisetron, 45% with droperidol and 98% with granisetron plus droperidol, respectively; the corresponding incidence during 3-24 h after anaesthesia was 78%, 38% and 98% (P< 0.05; overall chi-squared test with Yates continuity correction). No clinically important adverse events were observed in any of the groups. In conclusion, a combination of granisetron and droperidol was more effective than granisetron or droperidol as a sole antiemetic for the prevention of postoperative vomiting in children undergoing strabismus repair.

Analysis of Variance↗
PubMed2000

Tropisetron plus dexamethasone is more effective than tropisetron alone for the prevention of postoperative nausea and vomiting in children undergoing tonsillectomy.

The 5-HT3 antagonists are effective in reducing postoperative nausea and vomiting (PONV) associated with paediatric tonsillectomy. Although prophylactic tropisetron can reduce the incidence of PONV by half, the resulting level of over 40% is still unacceptably high. The aim of this study was to evaluate the effect of adding dexamethasone to tropisetron. In a blinded study, 59 children (mean age 6.1 years) were administered 0.1 mg.kg-1 up to 2 mg of tropisetron and 66 children (mean age 5.7 years) received the same dose of tropisetron plus 0.5 mg.kg-1 up to 8 mg of dexamethasone. Both drugs were given intravenously during induction of anaesthesia for tonsillectomy. During the inpatient stay of 24 h, the incidence of postoperative vomiting in the tropisetron alone group was 53% compared with 26% in the combination group (P=0.002, chi-squared). A significant reduction in nausea from 53% to 30% was also observed (P=0.02). Parents completed a daily diary for 5 days following discharge. Delayed vomiting occurred in 27% and 11% of the tropisetron and combination therapy groups, respectively (P=0.025) Sixteen percent and 9%, respectively, required medical attention (P=0.27). Tropisetron plus dexamethasone is more effective than tropisetron alone in reducing the incidence of PONV following paediatric tonsillectomy.

Adolescent↗
PubMed2002

The addition of antiemetics to the morphine solution in patient controlled analgesia syringes used by children after an appendicectomy does not reduce the incidence of postoperative nausea and vomiting.

BACKGROUND: We studied the effect of intraoperative ondansetron 0.1 mg x kg(-1) or droperidol 0.01 mg.kg-1, followed by the same dose of the antiemetic agent added to the morphine solution during patient controlled analgesia (PCA) on the incidence of nausea and vomiting in children following an appendicectomy. METHODS: Sixty children, aged 5-13 years, were recruited and randomly allocated to receive no prophylactic antiemetic, the control group (group C), ondansetron (group O) or droperidol (group D). The PCA pump was programmed to deliver a bolus dose of 20 microg x kg(-1) of morphine.with a 5-min lockout period and a background infusion of 4 microg x kg(-1) x h(-1). RESULTS: Postoperatively, the three groups were compared for nausea, vomiting and sedation scores for 24 h. The incidence of postoperative nausea and vomiting was 33% for group C, 44% for group O and 41% for group D. There was no increase in sedation scores in the droperidol group. CONCLUSIONS: We were unable to show any significant benefit from the prophylactic administration of ondansetron or droperidol to children using morphine PCA devices following appendicectomy in the doses we employed.

Analgesia, Patient-Controlled↗
PubMed2001

The development of a protocol for the use of 5-HT3 antagonists in chemotherapy-induced nausea and vomiting.

The purpose of this study was to evaluate the effectiveness of three 5-HT3 antagonists in routine clinical practice. The ultimate aim was to develop an antiemetic protocol, selecting a single 5-HT3 antagonist. Each of the drugs was studied for a 4-month period and data was collected from patients on nausea, vomiting (both acute and delayed) and side-effects by means of a diary card. A total of 274 patients were enrolled into the study. Success rates for acute emesis seen over the study period were in excess of 90%. There were no statistically significant differences between any of the three drugs investigated with respect to both acute and delayed nausea and vomiting. Similarly, there was no difference between the three groups for the incidence of constipation, diarrhoea and headache. Granisetron demonstrated a lesser deviation from the protocol in respect of the number of intravenous doses given to patients. The study allowed an effective 5-HT3 antagonist protocol to be developed for use in the management of nausea and vomiting in cancer patients.

Adolescent↗
PubMed2003

Abdominal migraine and cyclical vomiting.

Vomiting and abdominal pain are symptoms that may arise from a number of different causes. Cyclical vomiting and abdominal migraine are terms that have been applied to a presentation characterized by its episodic pattern and intervals of complete health. The 2 share many clinical features, but it is important to distinguish them as they have different responses to therapies such as prophylactic antimigraine medications. Both are noted for the absence of pathognomonic clinical features but also for the large number of other conditions to be considered in their differential diagnoses. Definitive diagnosis is frequently delayed. It is important to carefully evaluate these patients as well-being between vomiting episodes does not guarantee the absence of organic disease. While there is a role for a basic set of diagnostic tests, there is evidence to suggest that a trial of empiric therapy with upper gastrointestinal and small-bowel radiological studies is cost-effective.

Abdominal Pain↗
PubMed2002

Small dose of propofol for preventing nausea and vomiting after third molar extraction.

PURPOSE: The study goal was to evaluate the efficacy and safety of a small dose of propofol for the prevention of nausea and vomiting following third molar extraction. PATIENTS AND METHODS: In a prospective, randomized, double-blinded, placebo-controlled trial, 90 women received placebo or propofol at 2 different doses (0.25 mg/kg, 0.5 mg/kg) (n = 30 of each) intravenously at the end of surgery. A standard general anesthetic technique, including sevoflurane and nitrous oxide in oxygen, was employed throughout the surgical procedure. Emetic episodes and safety assessments were performed during 0 to 3 hours and 3 to 24 hours after after anesthesia. RESULTS: The rate of patients experiencing emesis-free (no nausea, retching, or vomiting) during 0 to 3 hours after anesthesia was 60% with placebo, 66% with propofol 0.25 mg/kg (P =.395), and 90% with propofol 0.5 mg/kg (P =.001); the corresponding rate during 3 to 24 hours after anesthesia was 60%, 63% (P = 0.5), and 87% (P =.02) (P values compared with placebo). No clinically serious adverse effects due to the study drug were observed in any group. CONCLUSIONS: Prophylactic therapy with a small dose (0.5 mg/kg) of propofol is effective for preventing postoperative nausea and vomiting in female patients undergoing general anesthesia for third molar extractions.

Adolescent↗
PubMed2001

Hypothetical framework for a relationship between maternal thyroid function, nausea and vomiting of pregnancy, and congenital heart disease.

Our objective was to investigate whether a relationship exists among maternal thyroid function, nausea and vomiting of pregnancy, and congenital heart disease. A Medline search from 1966 to the present was conducted to look for reports on the existence of this relationship. The results were supplemented by abstract searches and personal communication with relevant authors. Our search found independent evidence that maternal hyperthyroidism is related to increased rates of nausea and vomiting of pregnancy, which in turn is significantly related to a decrease in the incidence of congenital heart disease. Early evidence indicates that the converse may be true: maternal hypothyroidism and thyroid replacement therapy are associated with an increase in congenital heart disease in children. The potential relationship between maternal thyroid function, nausea and vomiting of pregnancy, and thyroid replacement therapy needs further study. We propose a case-control study of children presenting for echocardiography to elicit specific information regarding the pregnancy.

Female↗
PubMed2001

[Prophylaxis of nausea and vomiting after thyroid surgery: comparison of oral and intravenous dolasetron with intravenous droperidol and placebo].

OBJECTIVE: Postoperative nausea and vomiting (PONV) are among the most common complications in operative medicine. Especially thyroid surgery is frequently associated with PONV. It was the aim of this study to determine the efficacy of oral and intravenous dolasetron in comparison to intravenous droperidol (DHB) and placebo in the prevention of PONV. METHODS: 93 female and 43 male patients undergoing thyroid surgery were stratified according to gender and then randomised to receive double-blind one of four antiemetic regimes: 50 mg dolasetron given orally 45 minutes prior to induction of anaesthesia (group I), 12.5 mg dolasetron given intravenously during induction of anaesthesia (group II), 1.25 mg DHB given intravenously during induction of anaesthesia (group III) or placebo (group IV). General anaesthesia and preoperative management of the patients were standardised: premedication with chloracepate-dipotassium, induction with thiopentone, sufentanil and rocuronium, maintenance with N2O/O2, sevoflurane and repetitive doses of sufentanil and rocuronium, postoperative analgesia with metamizol and piritramide, antiemetic rescue-treatment with dimenhydrinate, metoclopramide and triflupromazine. Number of emetic episodes, the need for additional antiemetics and adverse events were recorded for 24 hours. Efficacy was measured by "complete-response" (CR = 0 emetic episodes or 1 emetic episode after 4 hours and no rescue-treatment) and "total-response" (TR = complete response plus no nausea, i.e., < 5 mm VAS rating of patients maximum nausea). RESULTS: Men: Only Dolasetron given intravenously reduced nausea and vomiting significantly, Dolasetron given orally reduced nausea, but not vomiting, DHB had no significant effects: CR 72.7% (group I), 100% (group II), 80% (group III), 63.6% (group IV); TR 72.7% (group I), 81.8% (group II), 50% (group III), 36.4% (group IV). Women: In all three treatment groups significantly less patients suffered from PONV compared to the placebo group (p < 0.05). There were no differences between the treatment groups: CR 58.3% (group I), 45.8% (group II), 52.2% (group III), 18.1% (group IV); TR 37.5% (group I), 33.3% (group II), 39.1% (group III), 13.6% (group IV). There were no adverse events in any group. CONCLUSIONS: Our results confirm the expected high incidence of PONV after thyroid surgery, especially in female patients. Single doses of oral and intravenous dolasetron and intravenous droperidol reduced PONV effectively in female patients undergoing thyroid surgery. Dolasetron seems to be the more effective substance in male patients. Both substances can be administered safely and are well tolerated.

Administration, Oral↗
PubMed2006

[Treatment of chemotherapy-induced nausea and vomiting with 5-hydroxytryptamine type 3 receptor antagonists].

BACKGROUND AND OBJECTIVE: 5-hydroxytryptamine 3 (5-HT3) receptor antagonists have proved to be highly efficacious in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). However, several questions remain concerning the relative efficacy of various approved anti-emetics, especially with respect to dosage, duration and timing of administration, as well as differences in toxicity profiles. Thus it seemed appropriate to assess the current therapeutic results in routine daily practice, when applying antiemetic therapy according to established guidelines. PATIENTS AND METHODS: Within LINO e.V., a group of medical oncologists in private ambulant practice (LINO: Association of private-practice medical oncologists in Bavaria), a total of 738 cycles of moderately or highly emesis-inducing chemotherapy were randomly assigned to three treatment options: (1)granisetron 1 mg (GRA1). (2) 3 mg (GRA3), and (3) ondansetron 8 mg (OND8), each combined with 8 mg dexamethasone. Incidence and severity of acute (day 1) and delayed CINV (day 2-5) and the subjective assessment of efficacy were documented on questionnaires filled in by the patients. RESULTS: All of the three regimens adequately prevented vomiting in the majority of the patients. However, all measured effects showed an uniform trend towards slightly decreased efficacy with 8 mg of ondansetron. These differences were predominantly detected with respect to delayed CINV on days 2 to 5, especially after chemotherapy with anthracyclin/cyclophosphamide combination therapy. CONCLUSION: Granisetron, at two different dosage regimens, and ondasetron showed adequate reduction in chemotherapy-induced nausea and vomiting, but ondansetron worked slightly less so.

Antineoplastic Agents↗
PubMed1976

Jamaican vomiting sickness. Biochemical investigation of two cases.

We identified methylenecyclopropylacetic acid, a known metabolite of hypoglycin A, in the urine of two patients with Jamaican vomiting sickness. Excretion of unusual dicarboxylic acids such as 2-ethylmalonic, 2-methylsuccinic, glutaric, adipic and dicarboxylic acids with eight and 10 carbon chains were also detected in both patients. The amounts of these dicarboxylic acids were 70 to 1000 times higher than normal. These metabolites have also been identified in urine of hypoglycin-treated rats. This evidence links hypoglycin A to Jamaican vomiting sickness as its causative agent. Urinary excretion of short-chain fatty acids was also increased up to 300 times higher than normal. These results indicate that, despite their clinical and histologic similarities, the cause and biochemical mechanisms of Jamaican vomiting sickness differ distinctly from those of Reye's syndrome in which these abnormal urinary metabolites are not appreciably increased.

Animals↗
PubMed2002

Evidence-based view of safety and effectiveness of pharmacologic therapy for nausea and vomiting of pregnancy (NVP).

OBJECTIVE: Our goal was to review the safety and effectiveness of available antiemetics for treatment of nausea and vomiting of pregnancy. STUDY DESIGN: We performed a quantitative and qualitative overview of observational controlled studies for drug safety in pregnancy and randomized controlled trials for drug effectiveness for nausea and vomiting in pregnancy. RESULTS: All of the following are safe and effective for treatment of varying degrees of nausea and vomiting in pregnancy: Bendectin/Diclectin (doxylamine, pyridoxine, dicyclomine), antihistamine (H(1)) blockers, and phenothiazines; however, the magnitude of effect, particularly for phenothiazines, is in question and may differ among individual agents. Pyridoxine and vitamin B(12)are safe and may be effective. Metoclopramide, droperidol, and ondansetron may be effective, but safety data are insufficient to recommend them as first-line agents. Corticosteroids may not be as beneficial as first thought, and there may be a small teratogenic risk. The relative effectiveness of various agents is largely unknown. CONCLUSION: Many medications, particularly H(1)-antagonists and phenothiazines, are safe and effective for treatment of varying degrees of NVP.

Abnormalities, Drug-Induced↗