Objectives:
The main objective of this study is evaluation and comparison of analgesic effect of Methadone and Morphine on postoperative pain following thoracic surgery in opium addicted patients.
Design:
This is a double blind study on 60 patients undergoing elective thoracic surgery.
Setting and conduct:
The patients will be divided into two groups of 30 ones. The method of randomization is minimizing. However the patients do not know the administered medicine. After measuring patient’s vital signs general anesthesia will be given to them identically. The severity of pain is evaluated by an anesthesiologist who is blind to administered drug at the end of surgery in recovery room and during first 24 hours, using Visual Analogue Scale. During first 24 hours after surgery Meperidine is administered if the patient asks analgesic. Also severity of pain is recorded at first, third, 6th, 12th and 24th hour after surgery using Visual Analogue Scale. Then these data will be analyzed by using computer.
Participants including major eligibility criteria:
Inclusion criteria are: American Association of Anesthesiologists’ (ASA) classification of I or II; age 20 -65. Exclusion criteria are: ASA classification of 3-6 (severe systemic disorders); less than one year period of addiction.
Intervention:
In first group 0.1mg Methadone and in second group 0.1mg Morphine is injected 30 minutes before induction of anesthesia.
Main outcome measures:
The severity of pain is evaluated by an anesthesiologist at the end of surgery in recovery room and during first 24 hours, using Visual Analogue Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010912074N1
Registration date:2013-02-18, 1391/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Hoseyn Taravati
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1223 5011
Email address
shafahospital@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Methadone and Morphine on postoperative pain scale following thoracic surgery in opium addicted patients
Public title
Comparison of the effect of Methadone and Morphine on postoperative pain following surgery in opium addicted patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: American Association of Anesthesiologists’ (ASA) classification of I or II; age 20 -65; having thoracic surgery (thoracotomy or incision’s extent of 10cm, without removal of rib and duration of 3 hours or less); more than 12 months history of opium addiction (inhalation form) as described by DSM-IV codes and after obtaining informed consent.
Exclusion criteria are: ASA classification of 3-6 (severe systemic disorders such as Chronic Renal Failure and Chronic Heart Failure); non addicted patients; less than 12 months duration of addiction; addiction to drugs other than opium; consuming less than or more than 390mg of opium per day.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Kerman University of Medical Sciences
Street address
Jomhoori boulevard
City
Kerman
Postal code
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
k/90/314
Health conditions studied
1
Description of health condition studied
Opium Addiction
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
severity of pain
Timepoint
at first, third, 6th, 12th and 24th hour of post operation time
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Methadone (each ampoule contains 10mg Methadone made by Daroopakhsh) with dosage of 0.1mg/kg injecting IV 30 minutes before induction of anesthesia.
Category
Treatment - Drugs
2
Description
control: Morphine (each ampoule contains 10mg Morphine made by Daroopakhsh) with dosage of 0.1mg/kg injecting IV 30 minutes before induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital of Kerman
Full name of responsible person
Marziyeh Khosravi
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, 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
Marziyeh Khosravi
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Bahonar Hospital, Baghmelli Square
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
javadkordi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Seyed Hosein Taravati
Position
anesthesiologist
Other areas of specialty/work
Street address
Bahonar Hospital, Baghmelli Square
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
Housein taravati @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
Marziyeh Khosravi
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Bahonar Hospital, Baghmelli Square
City
Kerman
Postal code
Phone
00
Fax
Email
javadkordi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)