This study is surveying parentral paracetamol efficacy on pain intensity in patients came intubated to ICU after a major surgery.In a double-blind clinical trial study involving patients 18-69 years old came Intubated to ICU after the surgery randomly divided into two groups of 20 cases and controls. one group(case) recieved parentral paracetamol 1gr every 6h for 24 hour for pain control immediately after enterance to ICU and the other group(control) got 100cc normal salin only. two groups were compared for opioid consumption and pain intensity based on Behavioral Pain Score at 0,1,2,4,6,12,24 hours after surgery.patients were excluded if they were drug abuser or pregnant or had liver and renal disorders ,allergy or contraindication for opioid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202229113N1
Registration date:2012-05-19, 1391/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-19, 1391/02/30
Registrant information
Name
Leila Azinfar
Name of organization / entity
Ahwaz Jondishapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3704
Email address
azinfar.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondishapour Ahwaz University of Medical Science
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous paracetamol on opioid consumption in intubated patient after major surgery in ICU
Public title
Effect of paracetamol on opioid consumption after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:between 18 to 69 years old; mechanical ventilation after surgery;
Exclusion criteria:allergy;acute kidney and hepatic injury;need to resurgery;reintubation; pregnancy; smoker; drug abuse; counterindication for using opioids
Age
From 18 years old to 69 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
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Science
Street address
University City, Ahvaz
City
Ahvaz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
ETH-233
Health conditions studied
1
Description of health condition studied
Acute post operation pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Opioid consumption after surgery
Timepoint
0,1,2,4,6,12,24 hours after to arrived to ICU
Method of measurement
Behavioral Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
In case group we prescribe 1gr vial paracetamol in 100 cc normal salin IV infused every 6 hours in first 24 hours
Category
Treatment - Drugs
2
Description
In control group 100cc normal salin infused every 6 hours in first 24 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU Unit, Golestan Hospital
Full name of responsible person
Dr. Farhad Soltani
Street address
ICU Unit, Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Ahvaz University of Medical Science and Health Services
Full name of responsible person
Farhad Soltani
Street address
University City, Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ahvaz University of Medical Science and Health Services
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
Ahwaz Jondishapour University of Medical Science
Full name of responsible person
Farhad Soltani
Position
Chairman of ICU
Other areas of specialty/work
Street address
ICU Unit, Golestan Hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3037
Fax
+98 61 1374 3037
Email
fsoltan@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapour University of Medical Science
Full name of responsible person
Farhad Soltani
Position
Floship of ICU
Other areas of specialty/work
Street address
ICU Unit, Golestan Hospital, Ahvaz
City
Ahwaz
Postal code
Phone
+98 61 1374 3037
Fax
+98 61 1374 3037
Email
fsoltan@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapour University of Medical Science
Full name of responsible person
Leila Azinfar
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Tanin Building, Esfahan Ave., Golestan Street
City
Ahwaz
Postal code
Phone
+98 61 1374 3704
Fax
+98 61 1374 3037
Email
azinfar3@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)