Comparison between methadone and opium effectiveness in control of agitation due to withdrawal syndrome in opium addicted patients admitted to the ICU of Kerman Shaheed Bahonar hospital
Opium is the main abusing compound in Iran. In ICU opium addicted patients withdrawal syndrome will cause agitation and altering patient’s responsiveness. Thus we have to replace opium in these patients. The aim of this study is to evaluate opium tincture with methadone syrup as the standard replacement therapy. Based on DSM-4 criteria, 2 groups of opium addicted patients were randomly included to the study. If renal or hepatic failure accurse, patients will be excluded from the study. Age of patients population is between 18 to 60 yrs. Group 1 receive opium tincture and the other take methadone syrup as much as to put them in score 0 of Richmond agitation-sedation scale. And to control patients agitation; moreover, vital signs would be evaluated before, during and after the ending study.
Finally we evaluate that which of these medicines can control patient’s agitation and vital signs with minimum of dose and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107011836N2
Registration date:2011-09-15, 1390/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-15, 1390/06/24
Registrant information
Name
Seyed Mojtaba Sohrevardi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5001
Email address
smsohrevardi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between methadone and opium effectiveness in control of agitation due to withdrawal syndrome in opium addicted patients admitted to the ICU of Kerman Shaheed Bahonar hospital
Public title
Comparison between methadone and opium effectiveness in control of agitation due to withdrawal syndrome in opium addicted patients admitted to the ICU of Kerman Shaheed Bahonar Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Patients who addicted to opium and admitted to the ICU and they can tolerate methadon syrup or opium tincture by oral or gavage include to the study. If acute renal failure or hepatic failure happen to patients they will excluded from the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kerman university of medical sciences
Street address
Research advisory of KMU, Blvd jomhouri eslami
City
Kerman
Postal code
Approval date
2011-08-05, 1390/05/14
Ethics committee reference number
k/90/145
Health conditions studied
1
Description of health condition studied
opium addiction
ICD-10 code
F11.2
ICD-10 code description
Mental and behavioural disordes
Primary outcomes
1
Description
Richmond agitation-sedation score
Timepoint
BID
Method of measurement
standard richmond sheet
Secondary outcomes
1
Description
Respiratory rate
Timepoint
Multiple
Method of measurement
Ventilator
2
Description
Blood pressure
Timepoint
Every 3 hr
Method of measurement
Spyngomanometer
3
Description
Heart rate
Timepoint
Multiple
Method of measurement
Cardiovascular monitoring system
Intervention groups
1
Description
Intervention group take opium tincture to prevent withdrawal syndrome and reach Richmond scale to score0
Category
Treatment - Drugs
2
Description
Control group take methadon syrup for prevention of withdrawal syndrome and getting score 0 of Richmond scale
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Shahid Bahonar Hospital
Full name of responsible person
Street address
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Reza Malekpour Afshar
Street address
Vice chancellor for research
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Faculty member- clinical pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy
City
Kerman
Postal code
Phone
+98 913 451 2422
Fax
Email
smsohrevardi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Research Center
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Assisstant Proff.
Other areas of specialty/work
Street address
Faculty of Pharmacy,
City
Kerman
Postal code
Phone
+98 34 1320 5001
Fax
Email
smsohrevardi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Pharm D., Ph.D- Clinal Pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Haft bagh Blvd.
City
Kerman
Postal code
7616913555
Phone
+98 34 1320 5001
Fax
+98 34 1320 5003
Email
smsohrevardi@kmu.ac.irsmsohrevardi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)