Management of post-strabismus nausea and vomiting in children using ondansetron: a value-based comparison of outcomes.
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BACKGROUND: This study evaluated the clinical efficacy and cost-effectiveness of prophylactic ondansetron versus early ondansetron treatment in the management of postoperative nausea and vomiting (PONV) in children undergoing strabismus repair using clinically meaningful outcomes and value-based principles. METHODS: One hundred and fifty children were randomly assigned to either prophylactic (P) or early symptomatic treatment only (T) group (n = 75). Children in group P received ondansetron 100 micrograms kg-1 i.v. and those in group T received placebo at the end of the procedure. After surgery, at the earliest sign of nausea or vomiting, children in both groups received ondansetron 100 micrograms kg-1 i.v. Besides the incidence of PONV, non-surrogate (fast tracking time, duration of stay in the postanaesthesia care unit (PACU) and parental satisfaction scores), therapeutic (numbers needed to prevent and treat) and pharmacoeconomic (cost to benefit a child and cost per PONV-free child) outcome measures were evaluated. RESULTS: The incidences of PONV in the immediate, early, late and first 24-h periods were significantly less in group P (20, 12, 19 and 35% respectively) than in group T (37, 29, 47 and 72%, P < 0.05). Time to achieve fast-track eligibility and duration of PACU stay were significantly shorter in group P (P < 0.001). Children in group P had superior mean (SD) parental satisfaction scores (8.2 (1.8)) compared with those in group T (6.8 (1.7), P < 0.001). The number needed to prevent PONV was 2 and the number needed to treat PONV was 9. The cost to benefit a child was more than fourfold less and the cost per PONV-free child was 35% less in group P. CONCLUSIONS: Compared with early symptomatic treatment with ondansetron, prophylactic ondansetron shortened fast-tracking time and duration of PACU stay and improved parental satisfaction and therapeutic outcomes at a lower direct cost. (+info)
Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting.
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BACKGROUND: Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand to ondansetron (Zofran) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. METHODS: A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand. The incidences of postoperative nausea and vomiting, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. RESULTS: Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 +/- 10 vs.70 +/- 20) and patient satisfaction (94 +/- 10 vs. 75 +/- 22) scores were significantly higher in the combination group the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. CONCLUSIONS: The ReliefBand compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery. (+info)
Comparison of acustimulation and ondansetron for the treatment of established postoperative nausea and vomiting.
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BACKGROUND: This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery. METHODS: After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery. RESULTS: The combination group had a significantly higher complete response rate than the acustimulation group (73% vs.40%, P <0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P < 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores. CONCLUSIONS: Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy. (+info)
Fetal and maternal effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery.
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BACKGROUND: In our routine practice, we observed a reduced incidence of fetal acidosis (umbilical artery pH < 7.20) at cesarean delivery during spinal anesthesia when a combination of phenylephrine and ephedrine was used as first line vasopressor therapy, compared with using ephedrine alone. METHODS: The study was randomized and double blind. It compared phenylephrine 100 microg/ml (phenylephrine group), ephedrine 3 mg/ml (ephedrine group), and phenylephrine 50 microg/ml combined with ephedrine 1.5 mg/ml (combination group), given by infusion, to maintain maternal systolic arterial pressure at baseline during spinal anesthesia for elective cesarean delivery. RESULTS: Fetal acidosis was less frequent in the phenylephrine group (1 of 48) (P = 0.004) and less frequent in the combination group (1 of 47) (P = 0.005) than in the ephedrine group (10 of 48). The mean systolic arterial pressure was similar for the three groups: Phenylephrine group median 98% (IQR 94-103) of baseline, ephedrine group 100% (96-106) and combination group 101% (97-108) (P = 0.11). The mean heart rate was higher in the ephedrine group (median 107% [IQR 99-118] of baseline) than in the phenylephrine group (88% [82-98]) (P < 0.0001), or the combination group (96% [86-102]) (P < 0.0001). Nausea and vomiting were less frequent in the phenylephrine group (nausea 17%, vomiting 0%) than in the ephedrine group (nausea 66%, vomiting 36%) (P < 0.0001), or the combination group (nausea 55%, vomiting 18%) (P < 0.0001). CONCLUSIONS: Giving phenylephrine alone by infusion at cesarean delivery was associated with a lower incidence of fetal acidosis and maternal nausea and vomiting than giving ephedrine alone. There was no advantage to combining phenylephrine and ephedrine because it increased nausea and vomiting, and it did not further improve fetal blood gas values, compared with giving phenylephrine alone. (+info)
Difference in risk factors for postoperative nausea and vomiting.
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BACKGROUND: It is commonly stated that risk factors for postoperative nausea are the same as for vomiting. The authors designed a prospective study to identify and differentiate the risk factors for postoperative nausea and vomiting in various surgical populations in a clinical audit setting. METHODS: The study included 671 consecutive surgical inpatients, aged 15 yr or more, undergoing various procedures. The study focused on postoperative nausea visual analog scale scores every 4 h and vomiting episodes within 72 h. Both vomiting and retching were considered as emetic events. Patient-, anesthesia-, and surgery-related variables that were considered to have a possible effect on the proportion of patients experiencing postoperative nausea and/or vomiting were examined. The bivariate Dale model for binary correlated outcomes was used to identify selectively the potential risk factors of postoperative nausea and vomiting. RESULTS: Among the 671 patients in the study, 126 (19%) reported one or more episodes of nausea, and 66 patients (10%) suffered one or more emetic episodes during the studied period. There was a highly significant association between the two outcomes. Some risk factors were predictive of both nausea and vomiting (female gender, nonsmoking status, and general anesthesia). History of migraine and type of surgery were mainly responsible for nausea but not for vomiting. The predictive effect of risk factors was controlled for postoperative pain and analgesic drugs. CONCLUSION: This study shows that differences exist in risk factors of postoperative nausea and vomiting. These could be explained by differences in the physiopathology of the two symptoms. (+info)
Dolasetron prophylaxis reduces nausea and postanaesthesia recovery time after remifentanil infusion during monitored anaesthesia care for extracorporeal shock wave lithotripsy.
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BACKGROUND: Remifentanil is used as an analgesic for different procedures performed during monitored anaesthesia care. Opioid-induced nausea and vomiting can be troublesome. METHODS: This prospective, randomized, double-blind study was performed to evaluate the efficacy of prophylaxis with dolasetron in reducing the frequency of postoperative nausea and duration of discharge time. Forty urological patients, undergoing elective ambulatory extracorporeal shock wave lithotripsy (ESWL) received randomly either dolasetron 12.5 mg i.v. (Group 1) or placebo (Group 2) 10 min before a patient-adapted continuous infusion of remifentanil 0.15-0.4 micro g kg(-1) min(-1) was administered. Frequency and intensity (VAS 0-100 mm) of nausea, retching, and vomiting were assessed by patients and blinded investigators during and after the procedure. RESULTS: Patient characteristics, baseline values, duration of ESWL, and total dose of remifentanil did not differ between groups. The frequency (Group 1/Group 2; 20/55%; P<0.05) and mean (SD) maximal intensity [15 (9)/45 (14) mm; P<0.05] of nausea during 24 h was significantly reduced after dolasetron and discharge times in Group 1 were less than Group 2 [22 (14)/45 (28) min; P<0.05]. (+info)
Antiemetic prophylaxis for office-based surgery: are the 5-HT3 receptor antagonists beneficial?
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BACKGROUND: Office-based surgery has become increasingly popular because of its cost-saving potential. However, the occurrence of postoperative nausea and vomiting (PONV) can delay patient discharge. Prophylaxis using a combination of antiemetic drugs has been suggested as an effective strategy for minimizing PONV. The authors designed this randomized, double-blinded, placebo-controlled study to assess the efficacy of ondansetron and dolasetron when administered in combination with droperidol and dexamethasone for routine antiemetic prophylaxis against PONV in the office-based surgery setting. METHODS: Following institutional review board approval, 135 consenting outpatients with American Society of Anesthesiologists physical status I-III who were undergoing superficial surgical procedures lasting 20-40 min were randomly assigned to one of three antiemetic treatment groups. Propofol was administered for induction of anesthesia, followed by 2-4% desflurane with 67% nitrous oxide in oxygen. Desflurane was subsequently adjusted to maintain a clinically adequate depth of anesthesia with an electroencephalographic Bispectral Index value between 50 and 60. All patients received 0.625 mg intravenous droperidol and 4 mg intravenous dexamethasone after induction of anesthesia. The study medication, containing normal saline (control), 12.5 mg intravenous dolasetron, or 4 mg intravenous ondansetron, was administered prior to the end of surgery. All patients received local anesthetics at the incisional site and 30 mg intravenous ketolorac to minimize postoperative pain. Recovery profiles, incidence of PONV, requirement for rescue antiemetic drugs, complete response rates, and patient satisfaction were assessed. RESULTS: The recovery times to patient orientation, oral intake, ambulation, and actual discharge did not differ among the three groups. The incidence of PONV, nausea scores, and requirement for rescue antiemetics were also similar in all three groups during the 24-h study period. In addition, the complete response rates to the prophylactic antiemetics (96-98%) and percentages of very satisfied patients (93-98%) were equally high in all three groups. However, the antiemetic drug acquisition costs were US $2.50, $15.50, and $18.50 in the control, dolasetron, and ondansetron groups, respectively. CONCLUSION: The addition of dolasetron (12.5 mg) or ondansetron (4 mg) failed to improve the antiemetic efficacy of droperidol (0.625 mg intravenous) and dexamethasone (4 mg intravenous) when they were used for routine prophylaxis in the office-based surgery setting. (+info)
Relative value to surgical patients and anesthesia providers of selected anesthesia related outcomes.
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BACKGROUND: Anesthesia side effects are almost inevitable in most situations. In order to optimize the anesthetic experience from the patient's viewpoint, it makes intuitive sense to attempt to avoid the side effects that the patient fears the most. METHODS: We obtained rankings and quantitative estimates of the relative importance of nine experiences that commonly occur after anesthesia and surgery from 109 patients prior to their surgery and from 30 anesthesiologists. RESULTS: Pain was the most important thing to avoid, and subjects allocated a median of 25 dollars of an imaginary 100 dollars to avoiding it. Next came vomiting (20 dollars), nausea (10 dollars), urinary retention (5 dollars) , myalgia (2 dollars) and pruritus (2 dollars) . Avoiding blood transfusion, an awake anesthetic technique or postoperative somnolence was not given value by the group as a whole. Anesthesiologists valued perioperative experiences in the same way as patients. CONCLUSIONS: Our results are comparable with those of previous studies in the area, and suggest that patients can prioritize the perioperative experiences they wish to avoid during their perioperative care. Such data, if obtained in the appropriate fashion, would enable anesthetic techniques to be compared using decision analysis. (+info)