The purpose of this study was to comparison of intravenous haloperidol and midazolam effects on patients' symptoms with conversion disorders referred to emergency department. In this double blinded clinical trial 140 patients aged 18- 60 years old with conversion disorders referred to emergency department in 1394-1396 were involved. Patients with abnormal vital signs, younger than 18 and older than 60 years old, pregnancy, history of drug abuse, hepatic and renal disorders and history of epilepsy were excluded.
patients were randomly divided in two groups: haloperidol or midazolam. In hallopridol group, patients received intravenous haloperidol 2.5 mg and in midazolam group patients received intravenous midazolam 2.5 mg too. Cardiac monitoring and direct observation was performed by resident. Sensory and movement disorders and consciousness degree was recorded before and after the intervention. Recovery degree, recovery duration and drug side effects was recorded too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100712050N2
Registration date:2016-01-25, 1394/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Mohamadali Jafari Nodushan
Name of organization / entity
Shahid Sadoughi University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 4313
Email address
malijafari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences.
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous haloperidol and midazolam effects on patients' symptoms with conversion disorders referred to emergency department
Public title
Comparison of intravenous haloperidol and midazolam effects on patients' symptoms with conversion disorders referred to emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients aged 18 -60 years old with conversion disorders referred to emergency department in 1394-1396.
Exclusion criteria: patients with abnormal vital signs; younger than 18 and older than 60 years old; pregnancy; history of drug abuse; hepatic and renal disorders; history of epilepsy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi of medical sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.156
Health conditions studied
1
Description of health condition studied
conversion disorders
ICD-10 code
F44
ICD-10 code description
Dissociative [conversion] disorders
Primary outcomes
1
Description
sensory disorder
Timepoint
before and after intervention
Method of measurement
observational
2
Description
movement disorder
Timepoint
before and after intervention
Method of measurement
observational
3
Description
Consciousness disorder
Timepoint
before and after intervention
Method of measurement
observational
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: intravenous haloperidol 2.5 mg stat
Category
Treatment - Drugs
2
Description
intervention group 2: intravenous midazolam 2.5 mg stat
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Street address
Shahid Sadoughi hospital -Ave Sina Blvd- Safaiye
City
Yazd
2
Recruitment center
Name of recruitment center
Shahid Rahnemon hospital
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Street address
Shahid Rahnemon hospital- Farokhi Ave
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Shahid Sadoughi university of medical sciences.
Full name of responsible person
Dr Habib Nikokar
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Shahid Sadoughi university of medical sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
assistante prof
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
malijafari@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
assistante prof
Other areas of specialty/work
Street address
Shaid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
malijafari@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Jafari Nodoshan
Position
assistante prof
Other areas of specialty/work
Street address
Shaid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
malijafari@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)