Evaluation of the effectiveness of Haloperidol and quetiapine in Delirium
Design
This is a double blind randomized control trail with control group (parallel group). patients will be divided in to two 100 participants based on random table.
Settings and conduct
Patients who referred to Emem Reza hospital emergency department and intensive care unit with delirium will be enrolled the study, from the April to August 2018 . Participant, care provider, outcome assessor and data analysts would be unaware of administered drug.
Participants/Inclusion and exclusion criteria
Patients diagnosed delirium aged more than 18 years based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) will enrolled the study. Long QTC interval syndrome and delirium syndrome occur because of alcohol withdrawal or benzodiazepines will be excluded
Intervention groups
first intervention group: 5 mg Haloperidol (IM)
second intervention group: 25 mg quetiapine (oral)
Main outcome variables
Delirium severity score regard to Delirium Rating Scale-Revised-98 (DRS-R-98)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121231011956N10
Registration date:2018-04-21, 1397/02/01
Registration timing:registered_while_recruiting
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effectiveness of Haloperidol and quetiapine for delirium in the Emergency department and intensive Care Unit
Public title
Effectiveness of Haloperidol and quetiapine in delirium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Delirium based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Participant, Care provider, Outcome assessor and Data analyser would be unaware of administered drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.MUMS.fm.REC.1396.599
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
An etiologically nonspecific organic cerebral syndrome characterized by concurrent disturbances of consciousness and attention, perception, thinking, memory, psychomotor behaviour, emotion, and the sleep-wake schedule. The duration is variable and the deg
Primary outcomes
1
Description
Delirium severity score regard to Delirium Rating Scale-Revised-98 (DRS-R-98)