Droperidol, Ondansetron, Placebo Antiemetic Trial for adult Emergency Department patients with nausea. (DOPAT)

Droperidol and Ondansetron compared with Placebo: a randomized controlled Antiemetic Trial of adult patients with nausea in the Emergency Department. (DOPAT)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000224325

Acronym

DOPAT

Enrollment

378

Registered

2017-02-10

Start date

2017-03-14

Completion date

2017-06-14

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study Purpose: Previous ED-based antiemetic research has failed to show a benefit of antiemetic drugs over placebo, with the possible exception of droperidol 1.25 mg IV. This has led to doubts about the value of ED antiemetic drug use, or further ED-based antiemetic research. Recent literature has suggested that the primary outcome measure in the ED-based placebo controlled RCTs to date (comparison of mean VAS change between groups) may not have been sensitive enough to detect true differences. Hence, for this study, an alternate primary outcome measure of VAS reduction in excess of 5 mm is being used, as this cut-off level has been shown to equate with symptom improvement. Study findings should then clarify whether or not antiemetic drugs do have value for ED patients, and may guide future research directions regarding antiemetic drug use in the ED.

Interventions

Arm D: Droperidol 1.25 mg intravenously, one dose only Arm O: Ondansetron 8 mg intravenously, one dose only

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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