Droperidol vs Ondansetron in Nausea Treatment in the Emergency Department (DONuT)

Phase 4

Completed

• Conditions: nausea; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Emergency medicine - Other emergency care

• Registration Number: ACTRN12619001205123
• Lead Sponsor: A/Prof Gabriel T Lau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-28
• Study Completion: 2021-08-18
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified