The aim of this study is to compare the pharmacokinetic parameters of intravenous and intramuscular methadone in critically ill patients. The study is designed as prospective, open label, and is performed on 40 critically ill patients in ICU, who receive opioid for their pain. Patients should be younger than 65 years old and should not suffer renal or hepatic failure, also they should not have prior history of allergy to methadone. Patients are randomly assigned to two groups; one will receive IV methadone and the other one will receive IM methadone. Blood samples will be collected on the first and sixth day of the study, inorder to measure methadone blood level. The first consequence of this study would be methadone plasma concentration, and the second one is pharmacokinetic parameters based on plasma concentrations.
General information
Acronym
Pharmacokinetic of methadone in critically ill patients
IRCT registration information
IRCT registration number:IRCT2013012610817N3
Registration date:2013-06-28, 1392/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Kourosh Sadeghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8849 1340
Email address
sadeghik@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Siences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pharmacokinetic of intamuscular and intravenous methadone in critically ill patients
Public title
Pharmacokinetic of methadone in critically ill patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criterion: critically ill patients in ICU, who require pain management with opioids.
Exclusion criteria: hypersensitivity to methadone or any component of the formulation; patients older than 65 years old; patients with renal failure( Scr > 2mg/dl ,Urine Output <0.5cc/kg/hour) 4. ); patients with hepatic failure(hepatic enzymes more than 3 times normal); patients with Platelet less than 100000; mean arterial pressure less than 65 or who require inotrope or vasopressor and patient who suffer ALI (PaO2 /FIO2<300).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Siences
Street address
Tehran University of Medical Siences, Enghelaab Square, Tehran
City
Tehran
Postal code
Approval date
2013-06-02, 1392/03/12
Ethics committee reference number
20299
Health conditions studied
1
Description of health condition studied
critically ill patients in ICU
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma methadone concentration
Timepoint
1st and 6th day of the study
Method of measurement
chromatography
2
Description
Methadone plasma concentration
Timepoint
on 1st and 6th day, 1,4, 8 and 12 hours after the last dose
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Control, in this group , intramascular methadone is given to patients every 8 hour, in order to control their pain
Category
Treatment - Drugs
2
Description
Intervention, in this group, methadone is administerd to patients via intravascular route,5mg every 8 hour, to control their pain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
fatemeh saeedi
Street address
Tehran University of Medical Siences, Enghelab Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Siences
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
tehran university of medical sciences
Full name of responsible person
Dr kourosh sadeghi
Position
clinical pharmacist
Other areas of specialty/work
Street address
pharmacy faculty of tehran university of medical schools 16 azar street , enghelab square Tehran,
City
tehran
Postal code
Phone
+98 21 6695 9090
Fax
Email
sadeghik@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
tehran university of medical sciences
Full name of responsible person
Dr. mojtaba Mojtahedzadeh
Position
clinical pharmacist
Other areas of specialty/work
Street address
, Sina hospital, Hassan abad street,Imamkhomeini square,Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8555
Fax
Email
mojtahed@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azin Gheimati
Position
pharmacy student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences,Enghelab square,Tehran
City
Tehran
Postal code
Phone
+98 886066200210098
Fax
Email
AZIN_GHEIMATI@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)