Randomized Placebo-controlled Trial of Droperidol and Ondansetron for Adult Emergency Department Patients With Nausea.

OBJECTIVE: The objective was to separately compare effectiveness of 1.25 mg of intravenous (IV) droperidol and 8 mg of IV ondansetron with 0.9% saline placebo for adult emergency department (ED) patients with nausea. A novel primary outcome measure, expected to aid clinical interpretation of reported results, was employed. METHODS: A randomized controlled trial was conducted at the three EDs of Monash Health, Melbourne, Australia. The design was to demonstrate superiority of the active drugs over placebo. The primary outcome measure of symptom improvement was defined as a visual analog scale (VAS) rating change of -8 mm or more from baseline at 30 minutes posttreatment. Mean VAS changes per group and percentages experiencing the desired treatment effect were also compared. The study was concluded after recruitment of 215 of the planned 378 patients, as interim analysis confirmed that continuation could not result in a finding of superiority. RESULTS: Of 215 patients, 73 (34%), 71 (33%), and 71 (33%) received droperidol, ondansetron, and placebo. Symptom improvement occurred in 75% (95% confidence interval [CI] = 64% to 85%), 80% (95% CI = 69% to 89%), and 76% (95% CI = 64% to 85%), respectively. Mean VAS changes were -29 mm (95% CI = -36 to -23 mm), -34 mm (95% CI = -41 to -28 mm), and -24 mm (95% CI = -29 to -19 mm), respectively. Desired treatment effects were experienced by 77% (95% CI = 65% to 86%), 73% (95% CI = 61% to 83%), and 59% (95% CI = 47% to 71%), respectively. CONCLUSION: For adult ED patients with nausea, superiority was not demonstrated for droperidol or ondansetron over placebo.

Measurement and monitoring of nausea severity in emergency department patients: a comparison of scales and exploration of treatment efficacy outcome measures.

OBJECTIVES: The objective was to investigate the correlation of the visual analog scale (VAS) and numeric rating scale (NRS) for nausea severity measurement and to explore options for improved reporting of antiemetic efficacy trial results. METHODS: This was a multicenter observational study of adult emergency department (ED) patients with nausea. Participants rated severity at enrollment and 30 minutes posttreatment using an adjectival scale, a VAS, and an NRS. Posttreatment, patients described symptom change and rated satisfaction. RESULTS: Ratings were performed by 258 patients. Both the VAS (0 to 100 mm) and the NRS (0 to 10) discriminated between adjectival severity categories. Median ratings with interquartile ranges (IQRs) were "severe" VAS 90.5 (IQR = 79 to 97) and NRS 9 (IQR = 8 to 9), "moderate" VAS 59 (IQR = 48 to 71) and NRS 6 (IQR = 5 to 7), "mild" VAS 34 (IQR = 25 to 49) and NRS 4 (IQR = 3 to 5), and "none" VAS 5 (IQR = 0 to 9) and NRS 0 (IQR = 0 to 1). Correlation between the VAS and NRS was high (0.83, Spearman). For the VAS, median mm (IQR) reductions for posttreatment change were "a lot less" -42 (IQR = -26 to -58.5), "a little less" -20.5 (IQR = -11 to -33), "the same" -2 (IQR = -8 to 3.5), "a little more" 14 (IQR = -2 to 22), and "a lot more" 17 (IQR = 6 to 23) and for satisfaction were "very satisfied" -45 (IQR = -27 to 63), "satisfied" -27 (IQR = -13 to 46), "unsure" -15 (IQR = -3 to -24), "dissatisfied" 4.5 (IQR = -5.5 to 13.5), and "very dissatisfied" 8.5 (IQR = 0 to 23). A VAS cutoff of ≥-5 mm detected symptom improvement with sensitivity 91.6% (95% CI = 86.7% to 95.1%), specificity 72.1% (95% CI = 59.9% to 82.3%), and positive predictive value 90.2% (95% CI = 85.1% to 94.0%). CONCLUSIONS: The VAS and NRS correlate highly. A VAS cutoff level of ≥-5 mm was a good predictor of symptom improvement, suggesting that its inclusion as an outcome measure would enhance reporting in antiemetic efficacy trials.

Antiemetic use for nausea and vomiting in adult emergency department patients: randomized controlled trial comparing ondansetron, metoclopramide, and placebo.

STUDY OBJECTIVE: We compare efficacy of ondansetron and metoclopramide with placebo for adults with undifferentiated emergency department (ED) nausea and vomiting. METHODS: A prospective, randomized, double-blind, placebo-controlled trial was conducted in 2 metropolitan EDs in Melbourne, Australia. Eligible patients with ED nausea and vomiting were randomized to receive 4 mg intravenous ondansetron, 20 mg intravenous metoclopramide, or saline solution placebo. Primary outcome was mean change in visual analog scale (VAS) rating of nausea severity from enrollment to 30 minutes after study drug administration. Secondary outcomes included patient satisfaction, need for rescue antiemetic treatment, and adverse events. RESULTS: Of 270 recruited patients, 258 (95.6%) were available for analysis. Of these patients, 87 (33.7%) received ondansetron; 88 (34.1%), metoclopramide; and 83 (32.2%), placebo. Baseline characteristics between treatment groups and recruitment site were similar. Mean decrease in VAS score was 27 mm (95% confidence interval [CI] 22 to 33 mm) for ondansetron, 28 mm (95% CI 22 to 34 mm) for metoclopramide, and 23 mm (95% CI 16 to 30 mm) for placebo. Satisfaction with treatment was reported by 54.1% (95% CI 43.5% to 64.5%), 61.6% (95% CI 51.0% to 71.4%), and 59.5% (95% CI 48.4% to 69.9%) for ondansetron, metoclopramide, and placebo, respectively; rescue medication was required by 34.5% (95% CI 25.0% to 45.1%), 17.9% (95% CI 10.8% to 27.2%), and 36.3% (95% CI 26.3% to 47.2%), respectively. Nine minor adverse events were reported. CONCLUSION: Reductions in nausea severity for this adult ED nausea and vomiting population were similar for 4 mg intravenous ondansetron, 20 mg intravenous metoclopramide, and placebo. There was a trend toward greater reductions in VAS ratings and a lesser requirement for rescue medication in the antiemetic drug groups, but differences from the placebo group did not reach significance. The majority of patients in all groups were satisfied with treatment.

Treatment and assessment of emergency department nausea and vomiting in Australasia: a survey of anti-emetic management.

OBJECTIVE: To describe the treatment and assessment of emergency department nausea and vomiting (EDNV) in Australasia by Fellows of the Australasian College for Emergency Medicine (FACEM). To determine the influence of various factors on FACEM anti-emetic choice. To compare the influence of drug effectiveness, side effects, cost and pharmacy directives on adult EDNV anti-emetic choice between FACEM choosing the two most common first-line agents. METHODS: A cross-sectional survey of all FACEM practising in Australasian ED was conducted by mail-out in February 2009. RESULTS: Of all FACEM surveyed 48.7% (532/1092) responded. The most common first-line drugs for adult EDNV were metoclopramide (87.3%, 453/519), 5HT3 antagonists (7.9%, 41/519) and prochlorperazine (2.3%, 12/519). For paediatric EDNV, the most common first-line agents were 5HT3 antagonists (86.2%, 307/356), metoclopramide (6.7%, 24/356) and promethazine (5.1%, 18/356). For most FACEM anti-emetic choice was highly influenced by perceived drug efficacy (96.1%) and side effects (82.5%), and 32.9% of FACEM were highly influenced by drug cost. Few FACEM reported ED anti-emetic protocols for adults (13.0%) or children (16.7%) in their ED. FACEM seldom used scales or tools to measure EDNV severity in adult (2.5%) or paediatric (3.4%) patients. CONCLUSIONS: Fellows of the Australasian College for Emergency Medicine anti-emetic choice in Australasian ED has been described. The main influences on anti-emetic choice were patient age, perceived drug efficacy and drug side-effect profiles.