Prospective randomized, double-blind comparative study of dexamethasone, ondansetron, and ondansetron plus dexamethasone as prophylactic antiemetic therapy in patients undergoing day-case gynaecological surgery

Dexamethasone alone and in combination with selective 5-hydroxytryptaminereceptor antagonists is of benefit in the prophylaxis of post-operativenausea and vomiting. In this study, the effectiveness of sucha combination in comparison to either drug alone is investigatedin day case gynaecological surgery. A total of 177 patientswere randomized to three treatment groups: dexamethasone 8 mg,ondansetron 4 mg, and dexamethasone 8 mg plus ondansetron 4mg. The only significant difference between groups was seenin the first 3 h when failure of prophylaxis was more frequentin patients who had received dexamethasone alone (P=0.0085;Fisher’s exact probability test). Confidence intervalanalysis indicates a modest treatment effect for the combinationand the decision whether to perform a larger study depends uponwhether such an effect is clinically relevant. Br J Anaesth 2001; 87: 588–92     

Prophylactic ondansetron does not improve patient satisfaction in women using PCA after Caesarean section

Eighty-one consenting women undergoing elective Caesarean sectionunder spinal anaesthesia were randomly divided into two groups.In Group O patients, ondansetron 4 mg was given intravenouslyat the end of the surgery and 8 mg added to the morphine solutionin the PCA syringe. Patients in Group P received only morphinevia PCA syringe. Analgesia and nausea were measured until PCAwas discontinued 24 h after the operation. Women in the twogroups were similar with respect to age, duration of use ofthe PCA, amount of morphine used, previous history of PONV,and incidence of motion sickness and morning sickness duringthe current pregnancy. The number of women who complained ofnausea and those needing rescue antiemetic medication was significantlyless in Group O. However, there was no statistically significantdifference between the two groups in the patient’s perceptionof the control of nausea and their overall satisfaction. Itwas noted that PONV was more frequent among women who had significantmorning sickness during early pregnancy and ondansetron wasbeneficial in reducing PONV in these women. Although the ondansetronreduced the incidence of PONV and the need for further antiemeticmedication, this did not affect patient’s satisfactionregarding their postoperative care. Br J Anaesth 2001; 87: 502–4     

Dolasetron prophylaxis reduces nausea and postanaesthesia recovery time after remifentanil infusion during monitored anaesthesia care for extracorporeal shock wave lithotripsy

Background. Remifentanil is used as an analgesic for differentprocedures performed during monitored anaesthesia care. Opioid-inducednausea and vomiting can be troublesome. Methods. This prospective, randomized, double-blind study wasperformed to evaluate the efficacy of prophylaxis with dolasetronin reducing the frequency of postoperative nausea and durationof discharge time. Forty urological patients, undergoing electiveambulatory extracorporeal shock wave lithotripsy (ESWL) receivedrandomly either dolasetron 12.5 mg i.v. (Group 1) or placebo(Group 2) 10 min before a patient-adapted continuous infusionof remifentanil 0.15–0.4 µg kg^–1 min^–1was administered. Frequency and intensity (VAS 0–100 mm)of nausea, retching, and vomiting were assessed by patientsand blinded investigators during and after the procedure. Results. Patient characteristics, baseline values, durationof ESWL, and total dose of remifentanil did not differ betweengroups. The frequency (Group 1/Group 2; 20/55%; P<0.05) andmean (SD) maximal intensity [15 (9)/45 (14) mm; P<0.05] ofnausea during 24 h was significantly reduced after dolasetronand discharge times in Group 1 were less than Group 2[22 (14)/45 (28) min; P<0.05]. Br J Anaesth 2003; 90: 194–8     

A randomized controlled trial of the antiemetic effect of three doses of ondansetron after strabismus surgery in children

METHODS: One hundred and thirty-one healthy children, aged 31-152 months, undergoing strabismus surgery under general anaesthesia, were randomly allocated to one of four groups: group A received 0.04 mg.kg-1 ( identical with 1 mg.m-2) of ondansetron, group B 0.1 mg.kg-1 ( identical with 2.5 mg.m-2), group C 0.2 mg.kg-1 ( identical with 5 mg.m-2) and group D placebo, given intravenously following induction of anaesthesia. Morphine 0.15 mg.kg-1 was given intravenously, intraoperatively, to provide postoperative analgesia. Hourly records of emetic episodes were made for 24 h. RESULTS: A considerably higher proportion of children suffered emesis in the placebo group compared to the active treatment groups taken together, during the first 8 h of postoperative care (76% vs. 45%, P=0.002). During the first 8 h, only 25% of those in treatment group C suffered emesis, the number-needed-to-treat was 3. There was a statistically significant decrease in the chance of vomiting with increasing dose of ondansetron (P=0.03). By 24 h, the difference in the rate of emesis was less marked but still statistically significant (90% vs. 69%, P=0.03). CONCLUSION: Overall, children given ondansetron had less than one-half the risk of vomiting compared to those given placebo (hazard ratio 0.46, 95% confidence interval 0.29-0.74). The mean number of emetic episodes declined from 2.73 in the placebo group to 1.92 in treatment group C. There was no difference in the incidence of side-effects between groups.     

Comparative effects of intravenous ketorolac and pethidine on perioperative analgesia and postoperative nausea and vomiting (PONV) for paediatric strabismus surgery

BACKGROUND: Corrective strabismus surgery is associated with moderate pain and a very high incidence of postoperative nausea and vomiting (PONV). Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug, is a popular analgesic in adults. There are only limited published data on the use of intravenous ketorolac for paediatric analgesia perioperatively. This study evaluated and compared the emetic and analgesic effect of ketorolac with pethidine and its suitability for this kind of surgery. METHODS: Following institutional ethics committee approval and parental consent, 52 ASA class I children of age 2.5 to 15 yr were randomised to receive either ketorolac 0.9 mg kg-1 or pethidine 0.5 mg kg-1 given intravenously (i.v.). A blinded observer assessed recovery by Steward's method immediately after arrival at the post anaesthesia care unit (PACU), pain by validated Objective Pain Score (OPS) at 0 h, 1/2 h and 1 h after arrival at the PACU and PONV by Numeric Rank Score at specified time intervals. RESULTS: There were no differences in demographic data, anaesthesia time or surgery duration. Recovery scores, OPS and postoperative analgesic requirement were similar in both groups. PONV at various time intervals for the first 24 h, occurred more frequently in the pethidine group as compared to the ketorolac group (P < 0.001) There were no side effects observed with either drug. CONCLUSION: Ketorolac in a dose of 0.9 mg kg-1 i.v. at the induction of anaesthesia is as effective as pethidine 0.5 mg kg-1 i.v. as an analgesic and is associated with significantly less PONV.     

Prevention of postoperative nausea and vomiting after spinal morphine for Caesarean section: comparison of cyclizine,dexamethasone and placebo

Background. Low-dose intrathecal (spinal) morphine (0.1–0.2mg) for Caesarean section delivers excellent postoperative analgesiabut is associated with significant nausea and vomiting. We comparedthe antiemetic efficacy of cyclizine, dexamethasone, and placeboin this clinical setting. Methods. Ninety-nine women undergoing elective Caesarean sectionunder spinal anaesthesia were allocated randomly, in a double-blindstudy design, to receive either cyclizine 50 mg, dexamethasone8 mg, or placebo as a single-dose infusion in saline 0.9%, 100ml on completion of surgery. Spinal anaesthesia consisted of:hyperbaric bupivacaine 0.5%, 2.0 ml; fentanyl 10 µg; andspinal morphine 0.2 mg. The primary outcome measure was theincidence of nausea. Results. The incidence of nausea was significantly less in patientsreceiving cyclizine compared with dexamethasone and placebo(33 vs 60 and 67%, respectively, P<0.05). Severity of nauseaand number of vomiting episodes were also less at 3–6h in cyclizine patients. Overall satisfaction with postoperativecare at 24 h, expressed on a 100 mm visual analogue scale, wasgreater in cyclizine [78 (28)] than either dexamethasone [58(31), P=0.03] or placebo [51 (28), P=0.008]. Conclusion. We conclude that following spinal morphine 0.2 mgand fentanyl 10 µg analgesia for Caesarean section, cyclizine50 mg i.v. reduces the incidence of nausea compared with dexamethasone8 mg i.v. or placebo. It also lessens the severity of nauseaand vomiting, and increases maternal satisfaction in the earlypostoperative period. Br J Anaesth 2003; 90: 665–70     

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.     

Dexamethasone is as effective as ondansetron for the prevention of postoperative nausea and vomiting following breast surgery

INTRODUCTION: Postoperative nausea and vomiting remain a common problem following breast surgery. This study assesses whether dexamethasone is as effective as ondansetron in the control of postoperative nausea and vomiting (PONV). METHODS: Eighty ASA I-III patients undergoing breast surgery for carcinoma of the breast were included in the study. Following premedication with diazepam 5-10 mg, patients were induced with fentanyl 50 micro g and propofol 2-2.5 mg kg-1. A larynx mask was inserted and anesthesia maintained with sevoflurane in oxygen and nitrous oxide. Patients were then randomly divided into two groups: Group D (dexamethasone) was given 4 mg dexamethasone i.v. after induction and Group O (ondansetron) was given 4 mg ondansetron at the same time point. Postoperatively, nausea, vomiting and pain were recorded at 1-h intervals during 4 h, and thereafter every 4 h during 24 h. RESULTS: The incidence of PONV during 24 h was 37% and 33% in Group D and Group O, respectively (NS). No differences were found between the groups in the incidence of postoperative nausea, vomiting or pain at the different time intervals. No differences were found in the incidence of PONV in smokers vs. non-smokers. No side-effects of these drugs were observed. CONCLUSIONS: Ondansetron 4 mg or dexamethasone 4 mg are equally effective in the prevention of postoperative nausea and vomiting following breast surgery. Other factors being similar, the difference in cost between these drugs would favor the use of dexamethasone instead of ondansetron when monotherapy against PONV is used.     

Applicability of risk scores for postoperative nausea and vomiting in adults to paediatric patients

Background. Scores to predict the occurrence of postoperativevomiting (PV) or nausea and vomiting (PONV) are well establishedin adult patients. The aim of this survey was to evaluate theapplicability of risk scores developed and tested in adult patientsin 983 paediatric patients (0–12 yr) undergoing varioussurgical procedures. Method. The predictive properties of five models were comparedwith respect to discriminating power (measured by the area undera receiver operating characteristic curve) and calibration (comparisonof the predicted and the actual incidences of the disease byweighed linear regression analysis). Results. The cumulative incidence of PV was 33.2% within 24h. The discriminating power was low and insufficient in allmodels tested (0.56–0.65). Furthermore, the predictedincidences of the scores correlated only vaguely with the actualincidences observed. Conclusion. Specialized scores for children are required. Thesemight use the history of PV, strabismus surgery, duration ofanaesthesia     

Efficacy of ondansetron and metoclopramide for preventing postoperative emesis following strabismus surgery in children

A double-blind, randomised, placebo-controlled trial was conducted to compare the efficacy of metoclopramide with the 5-HT₃ antagonist, ondansetron, for the prevention of postoperative emesis in children undergoing elective strabismus surgery. None of the children received any premedication and a similar anaesthetic technique was used for all. Ondansetron 0.15 mg.kg⁻¹, metoclopramide 0.25 mg.kg⁻¹ or saline placebo were administered following intravenous catheter placement. Episodes of emesis were recorded for the first 24 h for the intervals of 0–2, 2–6 and 6–24 h. The incidence of emesis in the first 24 h was observed to be 71.7% in the placebo group, 34.4% in the ondansetron group (p < 0.001) and 61.4% in the metoclopramide group (p = NS). The severity of vomiting was less in the ondansetron group as compared with metoclopramide (p < 0.01) and placebo (p < 0.001). Recovery room scores were comparable in all the groups. No serious side-effects were observed in the ondansetron group. We conclude that prophylactic ondansetron is effective and superior to metoclopramide in the prevention of postoperative emesis in children following elective strabismus surgery.     

Randomized prospective double-blind placebo-controlled trial of effect of intravenous ondansetron on intraocular pressure during ophthalmic surgery

The effect of i.v. ondansetron, before induction of anaesthesia,on intraocular pressure (IOP) in patients undergoing cataractsurgery was investigated. Forty patients (two groups of 20)received either ondansetron 4 mg (treatment group) or 0.9% saline(placebo group) in a double-blind controlled manner. There wereno significant differences in IOP between the groups. Ondansetronhad no significant effect on IOP during the study period. Br J Anaesth 2001; 87: 629–31     

Prophylactic ondansetron for postoperative emesis.Meta-analysis of its effectiveness in patients with previous history of postoperative nausea and vomiting

BACKGROUND: The objective of this study was to compare, by means of meta-analysis, the postoperative antiemetic efficacy of ondansetron in patients with and without antecedents of postoperative nausea and vomiting. METHODS: MEDLINE and EMBASE databases were searched for randomised placebo-controlled trials which evaluated the antiemetic effectiveness of 4 mg and 8 mg intravenous doses of prophylactic ondansetron in adult patients. A further selection was with respect to those studies which noted the patient's previous history of postoperative nausea and vomiting (PH-PONV) and, for the meta-analysis, the patients were divided into two sub-groups: those with (PH-PONV +) and those without a previous history of postoperative nausea and vomiting (PH-PONV -). Absence of vomiting was used as the index of effectiveness. RESULTS: Twenty-one trials involving 3984 patients (2446 in ondansetron groups and 1538 in placebo groups; 1163 PH-PONV(+) patients and 2821 PH-PONV(-) patients) met the selection criteria. The effectiveness of the 4 mg dose of ondansetron was: OR (95% CI)=2.40 (1.77-3.26) vs. 2.71 (2.23-3.30) for the patients of PH-PONV(+) and PH-PONV(-) sub-groups, respectively. For the 8 mg dose, the effectiveness of ondansetron was: PH-PONV(+)=4.21 (2.66-6.66) and PH-PONV(-)=2.61 (1.81-3.59). For neither of the doses evaluated was there any significant statistical difference between the sub-groups. CONCLUSIONS: The effectiveness of ondansetron in the prevention of postoperative vomiting is not affected by the patients' PH-PONV.     

Prophylactic therapy with granisetron in the prevention of vomiting after paediatric surgery. A randomized, double-blind comparison with droperidol and metoclopramide

The antiemetic efficacy of droperidol, metoclopramide and granisetron was compared with placebo in the reduction of vomiting after paediatric surgery (the extremities; inguinal hernia; and phimosis) during general inhalational anaesthesia. One hundred children, ASA physical status I, 4–10 years of age, were enrolled in a prospectively, randomized, double-blind investigation and assigned to one of four treatment regimens: placebo (saline, n=25), droperidol (50 μg·kg¹, n=25), metoclopramide (0.25 mg·kg-¹, n=25) or granisetron (40 μg·kg^-1, n=25). These drugs were administered intravenously (iv) after inhalation induction of anaesthesia. A complete response, defined as no emesis and no need for another rescue antiemetic during the first 24 h after anaesthesia, occurred in 60%, 76%, 68% and 88% of patients who had received placebo, droperidol, metoclopramide and granisetron, respectively (P<0.05; overall Fisher's exact probability test). The incidence of adverse events postoperatively was not different among the treatment groups. In conclusion, granisetron 40 μg·kg^-1 is a better antiemetic than droperidol and metoclopramide when compared to placebo for the prevention of postoperative emesis in children.     

Ondansetron reduces nausea and vomiting after paediatric adenotonsillectomy

The efficacy, safety and resource implications of a single intravenous dose of ondansetron (0.1 mg·kg⁻¹, maximum 4 mg) were assessed in a multinational, multicentre, randomized, double-blind, placebo-controlled trial of 427 children aged 1–12 years, undergoing tonsillectomy with/without adenoidectomy. Emesis (retching and/or vomiting) and nausea were analysed separately. Significantly more ondansetron-treated children had no episodes of emesis (127/212 (60%) vs 100/215 (47%); P =0.004) and experienced no postoperative nausea (135/211 (64%) vs 108/213 (51%); P =0.004) in the first 24 h. Ondansetron also reduced the number of emetic episodes ( P <0.001), the time to the first emetic episode ( P <0.001) and overall nausea severity ( P =0.003). Significantly fewer ondansetron-treated children were rescued or withdrawn from the study (5% vs 10%; P =0.042). Fewer ondansetron-treated patients required nursing intervention (34% vs 45%; P =0.007) and the average intervention time was significantly shorter (4.6 vs 8.1 minutes; P =0.001). Resources used to manage PONV were significantly reduced by ondansetron (43% vs 57%; P =0.014).