Protocol summary

Study aim
The effect of intravenous ketorolac and paracetamol on pain after coronary artery bypass graft surgery
Design
In this study 60 patients undergoing CaBG in Ahwaz Golestan Hospital will be randomly divided into 2 groups of 30 each based on randomized number table. All patients are monitored routine electrocardiography, pulse oximetry, invasive blood pressure measurement, expiratory carbon dioxide intake will be performed. They will receive the same drugs for induction and maintenance of anesthesia . After end of surgery and transfer to intensive care unit ,necessary monitoring ECG, IBP, Pulse Oximeter will be attached,thereafter the first group received 10 mg / kg of paracetamol diluted in 100 ml normal saline within 30 minutes, every 6 hours to 24 hours and in the second group 0.5 mg / kg diluted ketorolac in 100 cc normal saline within 30 minutes, every 6 hours to 24 hours
Settings and conduct
60 patients undergoing CABG in Ahwaz Golestan Hospital will be randomly divided into 2 groups of 30 each based on randomized number table. Kurdish. After the surgery is over and transferred to the intensive care unit The first group received 10 mg / kg of paracetamol and in the second group 0.5 mg / kg diluted ketorolac diluted in 100 ml normal saline within 30 minutes, every 6 hours to 24 hours
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 30-70 years Candidate for coronary artery bypass Exclusion criteria: gastrointestinal disease, kidney disease, liver disease, ejection fraction <30%, off-pump surgery
Intervention groups
The first group received 10 mg / kg paracetamol diluted in 100 ml normal saline within 30 minutes, every 6 hours to 24 hours. The second group received 0.5 mg / kg diluted ketorolac 100 cc normal saline within 30 minutes, every 6 hours to 24 hours
Main outcome variables
Age Sex Temperature Breath rate heart beat blood pressure The amount of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180909040979N4
Registration date: 2019-09-12, 1398/06/21
Registration timing: prospective

Last update: 2019-09-12, 1398/06/21
Update count: 0
Registration date
2019-09-12, 1398/06/21
Registrant information
Name
MARYAM ZAMANKHANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 4760
Email address
zamankhani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous ketorolac and paracetamol on pain after coronary artery bypass graft surgery
Public title
Comparison of the effect of intravenous ketorolac and paracetamol on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 and 70 years Candidate for coronary artery bypass graft
Exclusion criteria:
Gastrointestinal Disease Kidney disease Liver disease EF<30% Off pump surgery
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
According to the random number table, they will be divided into two groups of 30 people
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigator, intensive care nurses responsible for patient care blind to study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences., Research Deputy.,Blvd. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.AJUMS.REC.1398.050

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postoperative pain control
Timepoint
0, 6, 12 and 24 hours after extubation
Method of measurement
VAS

2

Description
Arterial oxygen saturation drop
Timepoint
0, 6, 12 and 24 hours after extubation
Method of measurement
Yes or no

3

Description
Blood pressure changes
Timepoint
0, 6, 12 and 24 hours after extubation
Method of measurement
Three groups: mild to moderate

4

Description
Chest tube discharge
Timepoint
0, 6, 12 and 24 hours after extubation
Method of measurement
The volume of discharge

Secondary outcomes

1

Description
arrhythmia
Timepoint
0, 6, 12 and 24 hours after exteubation
Method of measurement
monitoring

2

Description
Duration of ventilator dependence
Timepoint
0, 6, 12 and 24 hours after exteubation
Method of measurement
Duration of respiratory support

Intervention groups

1

Description
Intervention group: Intervention group: Paracetamol 10mg / kg diluted in 100 ml of normal saline for 30 minutes every 6 hours up to 24 hours
Category
Treatment - Drugs

2

Description
Intervention group: and in the second group 0.5 mg / kg diluted ketorolac in 100 ml of normal saline for 30 minutes, every 6 hours up to 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3017
Email
prc@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 3738
Email
mbadavi@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Javaherforoosh zadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 0168
Email
f_javaherforoosh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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