Aim of this study was determination of the effect of intravenous paracetamol on perioperative pain severity in coronary artery bypass graft surgery. Coronary artery bypass graft surgery candidates, enrolled in the study. They excluded from study because of excessive post-operative bleeding.
The study population was patients that had referred to Isfahan Chamran Heart Hospital for cardiac surgery. Sample volume was 110 patients that randomly divided in to two blank and trial groups (n=55)
This clinical trial was prospective, randomized, triple-blind, placebo-controlled and single-center. In paracetamol group: 15 minutes before induction of anesthesia and then every 6 hours for 3 days, 1 g paracetamol in 50 ml normal saline was infused in a 15-minute. In control group we use normal saline instead of paracetamol in all stages of study in the same volume.
The pain severity after surgery was evaluated based on two criteria, Facial analgesia scale and Visual analgesia scale at rest and after taking a deep breath.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101613181N2
Registration date:2015-11-17, 1394/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-17, 1394/08/26
Registrant information
Name
Mojtaba Mansouri
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1775 0252
Email address
mansouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2015-07-31, 1394/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of paracetamol on post-operative pain in coronary artery bypass graft surgery
Public title
Evaluation of the Effect of intravenous paracetamol on perioperative pain in coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
Inclusion criteria for the study were: undergoing elective surgery CABG, the individual agreement to participate in the study, age 40 to 70 years, not having liver failure (Serum bilirubin greater than 1.8 mg per deciliter and aspartate and alanine aminotransfraz more than 1.5 times of the upper limit of normal), not having renal failure (serum creatinine greater than 2 mg per deciliter), not addictive to opioid drugs and psychotropic substances, and having cardiac ejection fraction greater than 30%.,
Exclusion criteria for the study:
Excessive bleeding after surgery (more than 150 ml for the first two hours), having other surgeries in addition to coronary artery bypass surgery such as repair or replacement of heart valves, repeated surgery, and the need for aortic balloon support.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
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
IsfahanUniversity of Medical Sciences
Street address
Hezar Jarib st.
City
Isfahan
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
393595
Health conditions studied
1
Description of health condition studied
Perioperative pain
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
pain
Timepoint
during study
Method of measurement
VAS and FAS
Secondary outcomes
empty
Intervention groups
1
Description
In paracetamol group 15 minutes before induction of anesthesia 1 g intravenous paracetamol in 50 cc normal saline solution was infused to the patient within 15 minutes.
Next dose of paracetamol was 1 g which was infused intravenously over 15 minutes within 6-4 hours after the first dose, so that the injection time was during the last 20 minutes of surgery.
Then subsequent doses of paracetamol, every 6 hours for 3 days was injected in intensive care at a rate of 1 g.
Category
Prevention
2
Description
In the control group at all stages of paracetamol injection instead of paracetamol equal volume of normal saline was used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Hospital
Full name of responsible person
Mojtaba Mansouri
Street address
Chamran Heart Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Research Department
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan Univrsity of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate
Other areas of specialty/work
Street address
Isfahan Univrsity of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3775 0252
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Department of Anesthesiology
Full name of responsible person
Mojtaba Mansouri
Position
Associate
Other areas of specialty/work
Street address
Isfahan Univrsity of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3775 0252
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Univrsity of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate
Other areas of specialty/work
Street address
Isfahan Univrsity of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3775 0252
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)