In this study the effect of Melatonin are measured in 118 patients with head trauma in ICU. Patients aged 18 – 55 years and Glasgow Coma Score (GCS) more than 9 to less or equal to 13 were studied. Patients with history of mental disorders, psychotropic drug abuse, and organic brain disorder are excluded. All patients were divided into two groups, A and B. IN group A took Melatonin 5 mg orally at 9 pm o'clock and group B took 5mg synthetic tablet as placebo. In two groups, if agitation occurs, bolus Midazolam 0.02-0.04 mg / kg PRN (PRN"when necessary") intravenously to achieve Richmond score above 3, for pain control Morphine 0.02-0.04 mg / kg PRN intravenously to achieve a visual analog scale (VAS) less than 3 and if delirium occurred based on Confusion Assessment Method for the ICU (CAM-ICU) Haloperidol 0.02-0.04 mg / kg will be used. Melatonin has been improved control of agitation and delirium
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071016917N2
Registration date:2014-07-20, 1393/04/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melatonin on agitation and delirium in hospitalized patients with head trauma
Public title
Effect of Melatonin on the incidence of agitation and delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Age 18-55 years; Glasgow Coma Score (GCS) more than 9 to less or equal to 13
Exclusion criteria: History of mental disorders;Psychotropic drug abuse; Organic brain disorder
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341314
Health conditions studied
1
Description of health condition studied
Head injury
ICD-10 code
G90-G99
ICD-10 code description
Other disorders of the nervous system
Primary outcomes
1
Description
Delirium
Timepoint
Every 12 hours upto 10 days
Method of measurement
CAM-ICU
2
Description
Agitation
Timepoint
Every 12 hours to 10 days
Method of measurement
Richmond score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1:Melatonin 5mg oral dose every night at 9 pm upto 10 days
Category
Prevention
2
Description
Intervention 2:Synthetic oral placebo tablet
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Ali Ashraf
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Ali ashraf
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
nematihedieh@@gmail.com; arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)