Intravenous midazolam-droperidol (combination), droperidol (only) or olanzapine (only) for the acutely agitated patient: A multi-centre, randomised, double-blind, controlled, clinical trial

A randomised clinical trial to compare the efficacy of the intravenous midazolam-droperidol combination, droperidol only and olanzepine only for sedation of the severely agitated patient

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000980639

Acronym

SOOTHE Trial

Enrollment

349

Registered

2014-09-12

Start date

2014-10-20

Completion date

2015-08-29

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

We believe that the combination of midazolam and droperidol will be superior in efficacy and safety to droperidol alone or olanzapine alone for patients with acute agitation

Interventions

Arm 1: Single intravenous bolus of midazolam (5mg) plus droperidol (5mg). Arm 2: Single intravenous bolus of dropridol (10mg) Arm 3: Single intravenous bolus of olanzapine (10mg)

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 65 Years

Healthy volunteers

Inclusion criteria

Emergency Department patients aged 18-65 years who require IV drug sedation for acute agitation

Exclusion criteria

1. known hypersensitivity or contraindication to the study drugs 2. reversible aetiology for agitation (hypotension, hypoxia, hypoglycaemia) 3. known pregnancy 4. acute alcohol withdrawal (particularly amenable to benzodiazepines alone)

Outcome results