None listed
Conditions
Brief summary
The recent randomised controlled trial of Droperidol versus Midazolam for acute behaviour disturbance (ACTRN 12607000527460) resulted in the drug type being droperidol as effective at sedation as Midazolam but with significantly less adverse effects. There was no significant QT abnormalities. With ethics approval an extension to this trial followed and we have introduced a protocol of sedation with inclusion criteria and guidelines with the recommendation to give droperidol in a set dose and route as an observational study in the emergency department. This extension of the original trial has resulted in positive outcome for both patients and staff. The patient cohort is over 250 patients to date with no serious adverse effects. We now wish to extend this observational study to include rural regional and metropolitan hospitals to increase the sample size of the safety study.
Interventions
Droperidol 10 mg given by intramuscular injection administered for rapid sedation will be followed by a strict regime of monitoring of vital signs and an ECG recording The ECG will be obtained as soon as possible directly after the sedative has been given and at 4 hours or discharge Sedation scoring will be recorded throughout on a regime of 5 minutely for 20 minutes, again at 10 minutes, then half hourly until the patient wakes up or is calm. Any adverse drug effects will be noted and recorded.
Sponsors
A/Prof. G.K.Isbister
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Acute behaviour disturbance and is scoring +2 to +3 on the sedation assessment tool, defined as aggresive/violent loud outbusts and combative. The patient is at risk to themselves or others and requires physical restraint for safety.
Exclusion criteria
Under the age of 18 years. Is able to be talked down. Has agreed to the offer of oral medication with good result.
Outcome results
None listed