Randomized Placebo-controlled Trial of Droperidol and Ondansetron for Adult Emergency Department Patients With Nausea
| Autor: | Andis Graudins, James K. Fahey, Gabriel Blecher, Michaela J. Mee, Alastair Meyer, Diana Egerton-Warburton, Robert Meek, Pourya Pouryahya, Sallyanne Crow |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Adolescent Visual Analog Scale Visual analogue scale Nausea Placebo-controlled study Placebo law.invention Ondansetron 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method law Medicine Humans Droperidol Aged Aged 80 and over business.industry Australia 030208 emergency & critical care medicine General Medicine Middle Aged Interim analysis Anesthesia Emergency Medicine Antiemetics Female medicine.symptom business Emergency Service Hospital medicine.drug |
| Zdroj: | Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 26(8) |
| ISSN: | 1553-2712 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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