None listed
Conditions
Brief summary
Ondansetron is an anti-emetic drug that is commonly used in the emergency department to treat nausea and vomiting. Droperidol is an older anti-emetic medication where usage had fallen out of favour until recently, due to unfounded fears concerning QT prolongation. There is anecdotal evidence that IV droperidol is superior to ondansetron for treatment of nausea and vomiting. Although no difference was noted between the two drugs in a recent study, the dose of droperidol that was used was less that what would commonly be used in an emergency department setting. The question is if a higher dose of droperidol will likely demonstrate a difference.
Interventions
Droperidol 2.5mg intravenously. One dose only. Participants will be randomised into intervention or control group. Once the participant has been allocated to the intervention group, the treating physician will chart the intervention on the electronic medication chart and the intervention will be given by the treating nurse, which will be subsequently logged. Fidelity will be monitored by review of the electronic medication chart within the electronic medical record - which will document the
Droperidol 2.5mg intravenously. One dose only. Participants will be randomised into intervention or control group. Once the participant has been allocated to the intervention group, the treating physician will chart the intervention on the electronic medication chart and the intervention will be given by the treating nurse, which will be subsequently logged. Fidelity will be monitored by review of the electronic medication chart within the electronic medical record - which will document the time when the intervention was administered.
Sponsors
A/Prof Gabriel T Lau
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Emergency Department patients aged 18 years or more, with nausea and/or vomiting as a primary or secondary complaint (any underlying cause).
Exclusion criteria
* Known allergy to ondansetron or droperidol * Use of an agent with known antiemetic properties in the previous 4 hours, either prior to ED arrival, or earlier in the current ED episode of care. Includes: ondansetron, droperidol, metoclopramide, promethazine, chlorpromazine, prochlorperazine and any steroid medication. * Patients considered too unwell to consent or participate for any reason, including cardiovascular instability, hepatic failure, renal failure or altered mental state. * Contraindication to the administration of normal saline infusion during the study period (e.g. left ventricular failure, chronic renal failure) * Patients with Parkinson’s disease or restless leg syndrome. * Patients taking a dopamine antagonist for any reason. Includes: amisulpride, chlorpromazine, clopenthixol or flupenthixol, domperidone, haloperidol, paliperidone, quetiapine, risperidone, thioridazine. * Patients with cognitive impairment or language barrier which compromises understanding of the outcome measurements. * Patients with motion related nausea or vertigo, which have other specific recommended treatments, albeit with little supporting evidence * Pregnant or breast feeding women; ondansetron is category B and droperidol category C, with both being excreted to breast milk * Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV), which have other specific recommended antiemetic treatments * Inability to comply with an instruction to not drive or operate machinery for a minimum of 4 hours post-dosage; droperidol may impair these functions for a period of time, although 1.25 mg IV is a relatively small dose compared with dosages used for other indications
Outcome results
None listed