A randomised controlled trial for the management of acute behavioural disturbance comparing haloperidol versus droperidol for the most effective sedation in psychiatric intensive care patients.

Phase 4

Completed

• Conditions: Acute behavioural disturbance; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12611000565943
• Lead Sponsor: Dr G.K. Isbister

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1.Psychiatric intensive care patients with acute behavioural disturbance at risk to themselves or others;
AND
2.Require being placed in seclusion or physical restraint to protect themselves and others

Exclusion Criteria

1.Patients who are willing to take oral medication for sedation without physical restraint or seclusion;
2.Patients under the age of 18 years of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time from the administration of trial drug until sedation is achieved, determined by score on the Sedation Assessment Tool ( SAT) being reduced by two points or returned to zero (calm and alert).<br>Not a validated tool.[From the time of administration of the study drug until sedation is achieved.]

Secondary Outcome Measures

Name	Time	Method
2.Requirement for additional parenteral sedation as per the Sedation Assessment Tool ( SAT) score of +2 or +3 after 15 minutes after the initial administration.[From the time of administration of the study drug until 4 hours post dose];1.The frequency of adverse drug effects:<br> a. Oxygen desaturation < 90%<br> b. Airway obstruction<br> c. Hypotension (systolic BP < 90 mmHg)<br> d. Extrapyramidal side-effects<br>a,b and c are normal vital signs monitoring and are recorded routinely on the observation chart and data sheets. Extrapyramidal side effects are an observation made by clinicians and/or recorded and treated due to patient discomfort.[From the time of administration of the study drug until 1 hour post dose for a.b.c and d.];3.Incidence of injuries to the patients or staff members, as reported by members of staff.[From the time of administration of the study drug until 4 hours post dose]