Randomised trial of anti-emetics in pre-hospital care (The RAPS Trial)

In prehospital patients which antiemetic agent (maxolon, midazoloam or ondansetron) is superior in reducing nausea and vomiting

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000576325

Acronym

Randomised trial of Antiemetics in the Prehospital Setting (RAPS Trial)

Enrollment

450

Registered

2008-11-12

Start date

2008-11-07

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

There is little evidence that indicates which anti-emetic (a drug to treat nausea and vomiting) is most effective in the Emergency and pre-hospital setting despite the widespread clinical use of the agents. The aim of this study is to undertake a randomised controlled trial in the pre-hospital setting to evaluate the efficacy of 3 commonly used anti-emetics.

Interventions

Patients to receive either Ondansetron 4mg intramuscular injection Midazolam 2.5mg intramuscular injection These agents will be administered as a one off single intramuscular (IMI) injection. Followup will be continued until the patient has arrived at hospital - usually within 30 - 40 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients managed by the ambulance service who are either actively vomiting or have a nausea score greater or equal to 4

Exclusion criteria

Age less than 18 Received trial agents in the previous 24hours Pregnant or possibly pregnant Weight less than 60kg Altered conscious level (Glascow Coma Score < 15) Refuses intramuscular injection No consent

Outcome results